The Recall Desk

FDA (Devices) recall action 83467

Roche Diagnostics Operations, Inc. recalled 2 products on 2019-10-16

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-10-16
Critical
0
Units
61,655

Why these products were recalled

Inaccurately Low Sample Results

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-10-16

    Roche Vancomycin Test Recall Due to Inaccurate Low Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Distribution
    53 states