Z-1368-2013 Class II Terminated
FDA device recall Z-1368-2013 was initiated by Roche Diagnostics Operations, Inc. on Apr 4, 2013 and is designated Class II. 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… The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- Apr 4, 2013
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
Product Description
Cobas¿ 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
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
Distribution Pattern
USA Nationwide Distribution
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1368-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026