Z-1147-2019 Class II Terminated
FDA device recall Z-1147-2019 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
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
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