VITEK2 GP-ID, REF 21342 IVD
Check against the official notice below — it lists the full affected range.
Biomerieux Inc. is recalling VITEK 2 GP-ID cards (REF 21342) due to atypical negative reactions that have been reported and confirmed during quality control testing. The issue involves an unexpected negative O129R reaction for Enterococcus casseliflavus in three specific VITEK 2 GP ID lots, when the expected reaction according to the product instructions should be positive. As a precaution, the company is also recalling all GP ID card lots manufactured with the same raw materials. The recall affects 5,672 cartons distributed worldwide.
The affected product lot is identified by UDI 03573026131920 and Lot Number 2420348103. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.
Reason for recall: 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, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials. Distribution: worldwide Quantity: 5672 cartons Lot/code info: UDI 03573026131920, Lot Number 2420348103
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.