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Terminated

The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

FDA Recall Z-0490-2013 · Posted 2012-12-07

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2012-07-16
Date Terminated2015-07-22
Product Quantity855 units.

Reason for Recall

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Firm Action

Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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