Recall Z-0074-2018 ยท LQL Gram Positive Identification Panel
Biomerieux Inc
VITEK2 GP-ID, REF 21342 IVD
| Date | Oct 11, 2017 |
| Status | Terminated |
| Reason | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioMrieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials. |
| Root cause | Under Investigation by firm |
| Action | Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 10/11/2017. The direct consignees (subsidiaries and distributors) have until 11/11/2017 to notify their respective impacted users. 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 refere |
| Quantity | 5672 cartons |
| Distribution | worldwide |
| 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 |