Home / Recalls / Roche Diagnostics Operations, Inc. / Z-0108-2020

Z-0108-2020 Class II Terminated

Recalled by Roche Diagnostics Operations, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
October 16, 2019
Initiation Date
August 28, 2019
Termination Date
October 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,494 units

Product Description

cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

Reason for Recall

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

Distribution Pattern

Nationwide

Code Information

All serial numbers

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  • Z-3187-2024 Class II — Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In v (August 15, 2024)
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  • Z-1515-2022 Class II — cobas e801 Immunoassay Analyzer (July 14, 2022)
  • Z-0266-2022 Class II — Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 (October 18, 2021)
  • Z-2444-2021 Class II — cobas infinity central lab running software version 3.01.03 through 3.02.08, Cat (June 24, 2021)
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