The Recall Desk

FDA (Devices) recall action 81859

Roche Diagnostics Corporation recalled 3 products on 2019-04-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-04-24
Critical
0
Units
15,876

Why these products were recalled

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***

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2019-04-24

    Roche Bilirubin Total Gen.3 Recalled for Potential Medical Risk

    Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.

    Product
    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…
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    0 states
  • SevereFDA (Devices)··2019-04-24

    Roche Tina-quant IgM Gen.2 Recalled for Endogenous Interference

    Roche Diagnostics is recalling Tina-quant IgM Gen.2 assays due to new endogenous interference claims that may pose a medical risk on specific analyzers.

    Product
    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.
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    0 states
  • HighFDA (Devices)··2019-04-24

    Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims

    Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.

    Product
    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and…
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    0 states