The Recall Desk

FDA (Devices) recall action 78756

Roche Diagnostics Corporation recalled 2 products on 2018-02-07

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
2018-02-07
Critical
0
Units
1,178

Why these products were recalled

A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.

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)··2018-02-07

    Roche Elecsys 2010 Analyzer Software Malfunction Recall

    Roche Diagnostics is recalling 255 Elecsys 2010 analyzers due to a software malfunction that may cause data mismatches in sample and control files.

    Product
    Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecs
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-02-07

    Roche Recalls cobas e 411 Analyzers Due to Software Malfunction

    Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.

    Product
    cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated,
    Category
    Distribution
    0 states