Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product
FDA device recall Z-1368-2013 · posted 2013-05-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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
- Action taken
- Roche 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 72 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-04-04
- Date posted
- 2013-05-23
- Date terminated
- 2015-02-24
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |