Recall Z-1843-2014 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
BioFire Diagnostics, Inc.
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using th
| Date | Jun 20, 2014 (initiated May 27, 2014) |
| Status | Terminated |
| Reason | BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioMrieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus. |
| Root cause | Labeling design |
| Action | BioFire Diagnostics sent an Urgent Recall/Correction letter on May 28, 2014. Customers were instructed If the BCID Panel is used to test BacT/ALERT SN bottles, positive results for Pseudomonas aeruginosa and Enterococcus should be confirmed by another method prior to reporting the test results. Customer with questions were instructed contact customer support at Support@biofiredx.com or via telephone by dialing 1-800-735-6544 and selecting option 5 for customer support and then option 1 for FilmArray. For questions regarding this recall call 801-736-6354, ext 360. |
| Quantity | 1084 |
| Distribution | Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL Biofire Diagnostics, Inc., Jun 21, 2013 |