Recall Z-1146-2019— Roche Diagnostics Corporation

Name: FDA recall Z-1146-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2018-12-17, terminated 2020-11-02. It names one FDA 510(k) clearance: K964457. 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.. Reason: 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***.

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Terminated: 2020-11-02
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.·cleared 1997-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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***

Data sourced from openFDA. This site is unofficial and independent of the FDA.