The Recall Desk

FDA (Devices) recall action 83806

Roche Diagnostics Operations, Inc. recalled 2 products on 2019-10-23

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
2019-10-23
Critical
0
Units
2,304

Why these products were recalled

Due to low Quality Control recovery and invalid Calibration.

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

  • LowFDA (Devices)··2019-10-23

    Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits

    Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.

    Product
    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Distribution
    32 states
  • LowFDA (Devices)··2019-10-23

    Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues

    Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.

    Product
    Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
    Category
    Distribution
    32 states