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U.S. Department of Health and Human Services

Class 2 Device Recall Roche cobas e 602 module

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 Class 2 Device Recall Roche cobas e 602 modulesee related information
Date Initiated by FirmApril 04, 2013
Date PostedMay 23, 2013
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-1368-2013
Recall Event ID 64850
510(K)NumberK100853 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductCobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
Code Information Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02.
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTodd Siesky
317-521-3911
Manufacturer Reason
for Recall
When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
FDA Determined
Cause 2
Software design
ActionRoche sent an Urgent Medical Device Correction (UMDC) letter dated April 4, 2013 via UPS to all affected customers. The letter idenified the affected product, problem and instruction to be followed. Customers were instructed to consult with the physician or pathologist at their facility to determine specific clinical implications for patients. A future software version will correct this issue. Customers were asked to complete and fax back the UMDC attached fax form to 1-88-628-0730. Questions should be addresssed to Roche Diagnostics Technical Support 24 hours a day at 1-800-428-2336.
Quantity in Commerce72 units
DistributionUSA Nationwide Distribution
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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