FDA Enforcement
Class II
Terminated
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.
Recall: Z-1147-2019
·
Reported April 24, 2019
Enforcement
- Recall Number
- Z-1147-2019
- Event ID
- 81859
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2019
- Initiation Date
- December 17, 2018
- Classification Date
- April 13, 2019
- Termination Date
- November 2, 2020
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
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
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***
Code Info
n/a
Distribution
US Nationwide distribution.
Quantity
5292 analytical units