Recall Z-0296-2019 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,
| Date | Oct 30, 2018 (initiated Sep 5, 2018) |
| Status | Terminated |
| Reason | Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. |
| Root cause | Material/Component Contamination |
| Action | On 09/05/2018 the firm sent an Urgent Customer Advisory Notice to all customers via Federal Express (to US customers) and USPS (to Laboratory Directors for all organizations that have ordered kits) informing them that the firm has identified an increased risk of false positive Proteus results when the BioFire BCID Panel is used with BACT/ALERT Blood Culture Bottles: BACT/ALERT Blood Culture Bottle Catalog No. Description 410851 BACT/ALERT FA Plus 410852 BACT/ALERT FN Plus 410853 BACT/ |
| Quantity | 18038 |
| Distribution | Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam |
| 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 |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel Biofire Diagnostics, LLC, Jul 5, 2018 |