Z-1145-2019 Class II Terminated
FDA device recall Z-1145-2019 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
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***
Distribution Pattern
US Nationwide distribution.
Code Information
n/a