medical Class II Updated 2019-04-24

Roche Diagnostics Corporation recalls Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 118228

Recalled Product

Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

Hazard / Issue

New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: n/a
View official government recall

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