Home / Recalls / Roche Diagnostics Corporation / Z-1147-2019

Z-1147-2019 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

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

Other recalls by Roche Diagnostics Corporation

  • Z-1979-2019 Class II — The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies re (June 3, 2019)
  • Z-1928-2019 Class III — cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic samp (April 4, 2019)
  • Z-1927-2019 Class III — cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic samp (April 4, 2019)
  • Z-1194-2019 Class II — Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitati (March 18, 2019)
  • Z-1249-2019 Class II — cobas e 801 immunoassay analyzer (March 15, 2019)
  • Z-1368-2019 Class II — Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calcu (February 4, 2019)
  • Z-1146-2019 Class II — Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added (December 17, 2018)
  • Z-1145-2019 Class II — Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338 (December 17, 2018)
  • Z-0784-2019 Class II — Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche (December 17, 2018)
  • Z-1125-2019 Class II — cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatin (December 14, 2018)