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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
cobas® Integra 400/400 Plus 		see related information
Date Posted December 07, 2012
Recall Number Z-0490-2013
Product 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.
Code Information Device-associated diagnostic software
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7569
Reason for
Recall		 Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
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.
Quantity in Commerce 855 units.
Distribution Nationwide Distribution
 
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