FirmArray Blood Culture Identification recall
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed…
Why was FirmArray Blood Culture Identification recalled?
BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.
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?
426614,424514,424014,421114,419114,419214,417814,416214,416114,411214,411314,411014,410414,410014,408414,406314,404314,402314,403613,700113,698513,695313,692813,689813,689113,686313,685313,677713,668613,665013,667213,667113,663313,663013,665913,657313,659613,651413,647513,644613,632713,424614,424114,419514,419614,418014,416314,416414,412014,412114,411914,409914,406214,404414,700013,698413,695413,692913,689213,685413,668713,665113,667313,662913,657213,663913,660213,651513,647313,622213,
- Product
- FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed…
- Recalling firm
- BioFire Diagnostics, Inc.
- Quantity
- 1084
- Distribution
- Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)