The Recall Desk

FDA (Devices) recall action 81814

Roche Diagnostics Corporation recalled 2 products on 2019-04-17

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
2019-04-17
Critical
0
Units
793

Why these products were recalled

COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

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.

1–2 of 2

  • ModerateFDA (Devices)··2019-04-17

    Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over

    Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to me
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-04-17

    Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues

    Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

    Product
    COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number
    Category
    Distribution
    0 states