CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
FilmArray Blood Culture Identification recalled by BioFire Diagnostics
BioFire Diagnostics is recalling FilmArray Blood Culture Identification (Bcid) Panel Product Pouch Label: FilmArray Bcid, distributed nationwide in the US. The recall was initiated on 20 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2245-2021
- FDA event ID
- 88410
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2021
- FDA classified
- 11 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2021 | Recall initiated by company | |
| 11 Aug 2021 | Classified by FDA | +22 days |
| 18 Aug 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Where it was distributed
U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
Questions about this recall
Is FilmArray Blood Culture Identification (Bcid) Panel Product Pouch Label: FilmArray Bcid recalled?
Yes. BioFire Diagnostics recalled FilmArray Blood Culture Identification (Bcid) Panel Product Pouch Label: FilmArray Bcid on 20 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2245-2021.
Why was it recalled?
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Which lots are affected?
Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003
Where was it sold?
U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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