Recall Z-1145-2019— Roche Diagnostics Corporation

Name: FDA recall Z-1145-2019
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: K131544. Product: Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.. 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

K131544 — COBAS C BILIRUBIN TOTAL GEN.3Roche Diagnostics·cleared 2013-07-17

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

Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

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.