BioFire FilmArray BCID Panel Recall for False Positive Blood Culture Results
BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (false positive diagnostic results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray BCID Panel, an in vitro diagnostic (IVD) device, when used with specific BACT/ALERT blood culture bottles. The affected blood culture bottles are the BACT/ALERT FA Plus (Part Number 410851), BACT/ALERT FN Plus (Part Number 410852), and BACT/ALERT PF Plus (Part Number 410853). The recall covers 20,350 units distributed across 50 states, the District of Columbia, and the Northern Mariana Islands.
The recall is being issued because of an increased risk of false positive results for Enterobacteriaceae and Escherichia coli (E. coli) on the affected blood culture identification panels. This issue occurs specifically when the FilmArray BCID Panel is used in conjunction with the identified blood culture bottles.
Healthcare facilities and laboratories that have used or possess these specific combinations of the FilmArray BCID Panel and the listed BACT/ALERT blood culture bottles should stop using them and contact BioFire Diagnostics for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 20,350
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All lots of BCID Panels
- when used with the following blood culture bottles
- Part Number/Lot Numbers:410851/4052663
- 4052639
- 4052640
- 4052599
- 4052598
- 4052547
- 4052546
- 4052471
- 4052472
- 4052799
- 4052800
- 4052815
- 4052816
- 410852/4052871
- 4052872
- 4052459
- 4052458
- 4052565
Distribution
Related recalls
Same manufacturer · BioFire Diagnostics, LLC
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighBioFire Joint Infection Panel diagnostic test kit contamination recall
FDA (Devices) · 2026-05-13
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighRespiratory test panels recalled over elevated risk of false negative results
FDA (Devices) · 2025-12-03
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
Same hazard · false positive results
See all →- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- ModerateLeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
FDA (Devices) · 2026-04-29
- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- HighLeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
FDA (Devices) · 2026-04-29
- HighSolana Bordetella Complete Assay Kit Recalled for False Positive Results
FDA (Devices) · 2025-06-18