Z-2245-2021Class II

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No...

Name: Z-2245-2021 FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No...
Creator: BioFire Diagnostics, LLC
Published: 2021-07-20
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-07-20 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127 on 2021-07-20. FDA classified it as Class II and gives the reason as "Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error". 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-2245-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-20
Posted: 2021-08-12
Terminated: 2022-12-16
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at [email protected] or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.
Quantity in commerce: 29 kits
Distribution: U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
Product codes and lots: Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2245-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2245-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-11

Product code PEN

K181493Class IIFilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC / cleared 2018-07-05

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)