Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS IN
FDA device recall Z-0387-2017 · posted 2016-11-10 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
- Action taken
- Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 139
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-09-27
- Date posted
- 2016-11-10
- Date terminated
- 2017-07-21
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS C 111 ANALYZER (K071211) | Roche Diagnostics | 2007-07-30 |