Recall Z-3134-2017 ยท LQL Gram Positive Identification Panel
Biomerieux Inc
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) res
| Date | Aug 25, 2017 |
| Status | Terminated |
| Reason | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC 700327(TM) strain is positive. |
| Root cause | Under Investigation by firm |
| Action | bioMerieux sent an Urgent Product Removval Notice to all affected consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on August 25, 2017. . The directions to the user are as follows: "Please implement the following actions at this time: We request you take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Please refrain from using the referenced test kits (VITEK 2 GP ID, Lot |
| Quantity | 11,703 cartons |
| Distribution | US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, So |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) Biomerieux Vitek, Inc., Mar 12, 1996 |