Recall Z-1157-2021 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only
| Date | Jan 26, 2021 |
| Status | Terminated |
| Reason | The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials. |
| Root cause | Other |
| Action | On or around January 25, 2021, the firm send an UGENT: MEDICAL DEVICE CORRECTION letter via email to all affected consignees. The firm's recall strategy includes notification of all customers who have ordered the BCID or BCID2 Panel, within the last 12 months, using the aforementioned Customer Letters. The effectiveness of this communication will be verified by monitoring confirmation of the Acknowledgment of Receipt from each affected customer. |
| Quantity | 21,922 kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181493 | FilmArray Blood Culture Identification (BCID) Panel Biofire Diagnostics, LLC, Jul 5, 2018 |