The Recall Desk

FDA (Devices) recall action 79074

Roche Diagnostics Corporation recalled 3 products on 2018-04-04

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
2018-04-04
Critical
0
Units
—

Why these products were recalled

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

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

1–3 of 3

  • HighFDA (Devices)··2018-04-04

    Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.

    Product
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-04

    Roche cobas e 411 Analyzer Recall for Questionable Results

    Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.

    Product
    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-04

    Roche Modular E 170 Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.

    Product
    Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
    Category
    Distribution
    0 states