CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
BioFire BCID2 Panel recalled by BioFire Diagnostics
BioFire Diagnostics is recalling BioFire BCID2 Panel, distributed nationwide in the US. The recall was initiated on 10 May 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-1903-2021
- FDA event ID
- 87934
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2021
- FDA classified
- 21 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 May 2021 | Recall initiated by company | |
| 21 Jun 2021 | Classified by FDA | +42 days |
| 30 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Where it was distributed
US nationwide distribution
Questions about this recall
Is BioFire BCID2 Panel recalled?
Yes. BioFire Diagnostics recalled BioFire BCID2 Panel on 10 May 2021. The recall is Class II and its status is Terminated. Recall number Z-1903-2021.
Why was it recalled?
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.
Which lots are affected?
Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
Where was it sold?
US nationwide distribution
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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