BIOMÉRIEUX

FIELD ACTION NOTIFICATION

Field Action Type

FIELD SAFETY CORRECTIVE ACTION (FSCA)
General Information
FA Number: 5761-1 CRM Number: FA-010733
Product Name: BIOFIRE® FILMARRAY® TORCH Base
Subject: BIOFIRE® TORCH Base Power Supply
Type of Required Product Correction
Action:
Manufacturing Site: Salt Lake City Unit Name: Molecular
Linked to: Investigation Reference No.: N/A CI/CAPA No.: Other FA / CSN No.: N/A
CAPA-13585
Issue Date: October 24, 2023 Overall Due Date: December 24, 2023
Section A: Details

Impacted Product:

System/Product: BIOFIRE® FILMARRAY® TORCH

REF: Part No.: HTFA-ASY-0104 Shipping Configuration No.: HTFA-ASY-0001
Batch(es)/Serial: N/A – all serial numbers Business Unit: Clinical
Expiry: N/A GMDN Code: 48031
Software version(s): N/A EMDN Code: W02050116
Firmware version(s): N/A Unique Device Identifier: 00815381020253
Products released by Mftg site: N/A
Manufacturing Start and End Date: N/A
Shipment Start and End Date: N/A
Date of decision to take action in the field: October 18, 2023
Name and Address of Legal Manufacturer:
Name & Address of Recalling Firm: BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, Utah, 84108, USA
Name & Address of Manufacturing Site: BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City, Utah, 84108, USA
SIG code: NA009
Product Intended Use:
BioFire® FilmArray® Torch
The BioFire® FilmArray® Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use BioFire ®
FilmArray® Panels. The BioFire Torch is intended for use in combination with assay specific reagent pouches to detect multiple
nucleic acid targets contained in clinical specimens. The BioFire Torch interacts with the reagent pouch to both purify nucleic
acids and amplify targeted nucleic acid sequences using nested multiplex PCR (nmPCR) in a closed system. The resulting PCR
products are evaluated using assay-specific DNA melting analysis. The BioFire Torch software automatically determines the
results and provides a test report.

Description of the Issue:

Investigation Reference No.: CAPA-13585
Is there a PSS associated with this FA? YES NO If Yes, PSS No.:
Is a CI (cause investigation)/CAPA opened? YES NO If Yes, CI/CAPA No.: CAPA-13585
Is this FA associated with a customer complaint? YES NO If yes, list customer complaint numbers below.
Customer Complaint Numbers: CI-6595, CI-5718

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 1 of 7

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Issue Description:

When turning on BIOFIRE TORCH systems, arcing inside of the power switch may result in carbon build-up on the switch
contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the
power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short,
deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

Description of Actions:

 If a user determines that the BIOFIRE TORCH Base requires power cycling, each individual BIOFIRE TORCH Module
should be powered down prior to power cycling the base unit, OR,
 In lieu of power cycling the Torch Base, the ‘Reset’ button may be used according to the revised ‘Power On’ procedure in
the Operator’s Manual,
 More information can be found here: https://www.biofiredx.com/e-labeling/ITITORCH4131

Risk Assessment/Health Hazard Assessment/Industry Hazard Assessment:

Observed Risk:
Severity was assessed as SERIOUS.
The P1 probability was estimated as OCCASIONAL.
The P2 probability was assessed as OCCASIONAL.
Consequently, the overall probability was REMOTE.
As a conclusion, the overall observed risk was assessed as MINOR for electrical shorts.

Notification to Regulatory Authority:

Manual creation of Local Field Actions for management of reporting to health authorities are required for the countries that are
required to assess/report to health authorities for FCA-FSCA implemented outside of their country per 000584 – Attachment 4, Field
Action Reporting Matrix.

Customer Letter/Attachments:

Customer Letter BFR0002-5041 FSCA 5761 TORCH OUS Letter

Customer OUS AOR BFR0002-5042 FSCA 5761 TORCH OUS AOR
MEDDEV Annex IV Form FSCA 5761 MEDDEV Annex IV Initial Report Form

Section B: Required Actions

1. Please immediately acknowledge receipt (AR) of this FA.
 Subsidiaries and plants using CRM: Please manage the Acknowledgment of FA in CRM by changing the local
field action status from “new” to “in progress”.
 Subsidiaries or Export Distributors not using CRM: Please complete all of Sections D.1 and D.2, sign and date
where indicated, then send it by email to [email protected].
2. Identify all customers for which you are responsible that are impacted by the scope of this notification.

3. Implement the following required actions (when applicable):

a. Send initial notification to customer: To be completed within 1 month

Due date 24 November 2023
Recipients of this notification must notify all impacted customers using translated customer letter (if applicable). Initial customer
notification should be completed before the indicated due date unless local regulation specifies earlier due date.

- For Subsidiaries using CRM: Complete the date of initial customer notification and close the Service Task
“Send Initial Notification to customer”
- For Subsidiaries, Export Distributors or other entities not using CRM : Complete the paragraph A of the section
D.3, then send it by email to [email protected].

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 2 of 7

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b. Send reminder for customer letter: (if applicable based on your local regulation/procedure)
Recipients of this notification must define a customer reminder according to their local procedure. The customer reminder
should be completed before the indicated due date unless local regulation specifies earlier due date.

- For Subsidiaries using CRM: Complete the date of reminder customer notification and close the Service Task
“Send Reminder for customer letter”
- For Subsidiaries not using CRM: Complete the paragraph B of the section D.3, then send it by email to
[email protected].

c. Perform actions on product: To be completed within 2 months

Due date 24 December 2023
Recipients of this notification must apply the following action(s) before the indicated due date:
 Implement proper ‘Power On’ procedure as outlined in
https://www.biofiredx.com/e-labeling/ITITORCH4131

- For Subsidiaries, and plants, using CRM: Complete the date requested and close the Service Task “Perform
actions on product”
- For Subsidiaries, Export Distributors or other entities not using CRM : Complete the paragraph C of the section
D.3, then send it by email to [email protected].
-

d. Initial report to health authority: To be completed within 1 month

Due date 24 November 2023
Recipients of this notification must assess the product issue and any associated patient risk in accordance with local
regulations to determine if it is reportable to their local regulatory authority. Notification to their regulatory authority must
include device classification when required. Initial reporting to health authorities should be completed before the indicated due
date unless local regulation specifies earlier due date.

- For Subsidiaries using CRM: Complete the date and information requested in the Service task “Initial
Reporting to Health Authority”
- For Subsidiaries, Export Distributors or other entities not using CRM : Complete the paragraph D of the section
D.3, then send it by email to [email protected].

e. Report to health authority closure:

If required by the local procedures and regulation, recipient of this notification must send to their regulatory authority the
final/closure reports according to due date specified in your local regulation.

- For Subsidiaries using CRM: Complete the date and information requested in the local FA and in the
Service task “Report to Health Authority Closure”
- For Subsidiaries, Export Distributors or other entities not using CRM: Complete the paragraph D of the section
D.3, then send it by email to [email protected].

f. Perform delta management: (if applicable based on your local regulation/procedure) To be completed within 1 month
Due date 24 November 2023
Recipients of this notification must identify if new customer are impacted until the due date indicated.
- For Subsidiaries and plants using CRM: Complete the date and information requested in the Service
task “Perform Delta Management”
- For Subsidiaries or other entities not using CRM: Complete the paragraph E of the section D.3, then send it by
email to [email protected].

4. After all actions are completed, please:

a. For Subsidiaries and plants using CRM: Close the Local Field Action
b. For Subsidiaries or other entities not using CRM: Complete Sections D.1 and D.3 and return the acknowledgement of
completion (AC) in section D.4 by signing and indicating the date
NOTE: The Acknowledgement of Completion (AC) must be provided no later than the overall due date.

- Subsidiaries or other entities not using CRM: Once completed, upload to LiveLink.
- For Export Distributors not using CRM: Once completed, send it by email to [email protected].

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 3 of 7

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Issue date Revision Number Purpose of the revision

23 October 2023 Creation N/A
1
24 October 2023 (Update from 5761 to 5761-1) shipping configuration number added, HTFA-ASY-0001.
Section C: Contact

Stephanie Aswad
Regulatory Affairs Associate
Regulatory Affairs – BioFire
515 Colorow Drive, Salt Lake City, Utah, 84108, USA

 +1 801-588-0507 @ [email protected]

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 4 of 7

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Section D: Acknowledgement Form:

FA Number: 5761-1 CRM Number: FA-010733 FA Type/Title: FSCA: BioFire® TORCH Overall Due date:
Base Power Supply 24 December 2023

SECTION D.1: LOCATION

Group Company or Export Distributor Name(s) Country Account #
Vietmedical Distribution Joint Stock Company Viet Nam

------------------------------------------------------------------------------- -
SECTION D.2: ACKNOWLEDGEMENT OF RECEIPT (AR)

Print Name Mr Duong Duc Viet , Vietmedical Distribution Joint Stock Company
Sign Name
Position Technical Service
Date (dd/MMM/yyyy) 27/10/2023

------------------------------------------------------------------------------- -
SECTION D.3: ACTIONS REQUIRED (service tasks)
Check the appropriate box and follow the instructions for completion.

Field Action Not Applicable: Provide justification for each sections A, B, C, D and E.
Complete the signature box below in section D.4 and return form.

Field Action Applicable: Complete the following sections A, B, C, D and E.

Complete the signature box in section D.4 and return form.

A – Initial Notification to Customer

If Not Applicable: Provide justification: ……………………………………………………………………………

……………………………………………………………………………………………………
If Applicable: Complete the date of issuance of the initial customer letter in the space below.

Initial Customer Notification date (dd/MM/yyyy):

B – Send reminder for customer letter

If Not Applicable: Provide justification: ……………………………………………………………………………

……………………………………………………………………………………………………
If Applicable: Complete the following table:

Reminder customer Reminder Customer % customer answers

notification Notification date after the reminder
(dd/MMM/yyyy)
Reminder #1
Reminder #2
Reminder #3

Note : Not requested for Export Distributors

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 5 of 7

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C – Actions on Products

If Not Applicable: Provide justification: ……………………………………………………………………………

……………………………………………………………………………………………………

If Applicable: Date of completion (dd/MMM/yyyy) : ……………………………………………………….

And Complete the required information in the table below:
 If instrument/software, please use the following table:

Product Quantity Quantity Quantity

REF # Serial number #
Name impacted corrected** returned*
Part No.: HTFA-ASY-0104 BIOFIRE® N/A – all serial N/A N/A N/A
Shipping Configuration TORCH Base numbers
No.: HTFA-ASY-0001 System
* Quantity returned to bioMérieux subsidiary or export distributor

** Quantity corrected include software updates or instruments corrections.

D – Reporting to Health Authority

If Not Applicable: Provide justification: ……………………………………………………………………………

……………………………………………………………………………………………………
If Applicable: Complete the following data related to the reporting to health authorities:
Initial report to Health authority

NCA Reference Number:

Date of initial Report Submission (dd/MMM/yyyy):

Report to Health authority closure

Follow-up report Submission Date(s) (dd/MMM/yyyy):
Final report submission date (dd/MMM/yyyy):
Date of closure (dd/MMM/yyyy):

Questions from National Competent Authority (NCA) ? YES NO

Comments : …………………………………………………………………………………………………………………

Changes requested from National Competent Authority (NCA) YES NO

Comments : …………………………………………………………………………………………………………………

Closed by National Competent Authority (NCA) ? YES NO

Comments : …………………………………………………………………………………………………………………

E – DELTA MANAGEMENT

If Not Applicable: Provide justification: ……………………………………………………………………………

……………………………………………………………………………………………………
If Applicable: Complete the following :
Delta management date (dd/MMM/yyyy) :

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 6 of 7

Attachment 1 of LLDC - 004045 - Rev 11.A - Field Action Notification Communication Form FCA/FSCA – en – Editable
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SECTION D.4: ACKNOWLEDGEMENT OF COMPLETION (AC)

Complete the signature box below:

Print Name: Mr Hanh , Thai Nguyen General Hospital

Sign Name:

Position: Technical Department

Date (dd/MMM/yyyy): 24/11/2023

FA Number: 5761-1 FA Type/Title: FSCA: BIOFIRE® TORCH Base Power Supply INTERNAL USE ONLY Page 7 of 7

Attachment 1 of LLDC - 004045 - Rev 11.A - Field Action Notification Communication Form FCA/FSCA – en – Editable