Z-1146-2019 Class II Terminated
FDA device recall Z-1146-2019 was initiated by Roche Diagnostics Corporation on December 17, 2018 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated November 2, 2020). Affected quantity: 5292 analytical units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- December 17, 2018
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5292 analytical units
Product Description
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.
Reason for Recall
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***
Distribution Pattern
US Nationwide distribution.
Code Information
n/a