Recall Z-1513-2018 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
| Date | Apr 25, 2018 (initiated Mar 14, 2018) |
| Status | Terminated |
| Reason | There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. |
| Root cause | Material/Component Contamination |
| Action | The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018. |
| Distribution | Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, G |
| 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 |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC, Jan 30, 2015 |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch Biofire Diagnostics, LLC, Mar 15, 2016 |