BioFire BCID2 Panel recall
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI…
Why was BioFire BCID2 Panel 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
- Product
- BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI…
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 870 kits
- Distribution
- US nationwide distribution
- Recall date
- June 30, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)