The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Recall Z-0489-2013 · Posted 2012-12-07
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Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2012-07-16
Date Terminated2015-07-22
Product Quantity77 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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