Z-1903-2021Class II

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in...

Name: Z-1903-2021 BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in...
Creator: BioFire Diagnostics, LLC
Published: 2021-05-10
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-05-10 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338 on 2021-05-10. FDA classified it as Class II and gives the reason as "Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1903-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-10
Posted: 2021-06-21
Terminated: 2022-12-15
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scrapped (if any) on the attached acknowledgement of receipt form. 4. If you may have further distributed this product, please identify any recipients and notify them at once of this product recall. 5. Please complete the accompanying Field Action acknowledgement of receipt Form and return to BioFire so that BioFire may acknowledge your receipt of this notification. 6. If you have any questions or concerns, please contact our customer support department at [email protected] or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.
Quantity in commerce: 870 kits
Distribution: US nationwide distribution
Product codes and lots: Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1903-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1903-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

Product code PEN

K193519Class IIBioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)