The Recall Desk

FDA (Devices) recall action 83525

Roche Diagnostics Operations, Inc. recalled 3 products on 2019-09-11

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
2019-09-11
Critical
0
Units
22

Why these products were recalled

Quality issue with high pressure solenoid valves

Quality issue with high pressure solenoid valves may cause inaccurate 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

1–3 of 3

  • HighFDA (Devices)··2019-09-11

    Roche cobas e 601 Module Recalled for Inaccurate Results

    Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.

    Product
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
    Category
    Distribution
    15 states
  • HighFDA (Devices)··2019-09-11

    Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

    Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

    Product
    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
    Category
    Distribution
    15 states