Recall Z-0387-2017
Roche Diagnostics Operations, Inc. · initiated September 27, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Codes / lots: 04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-0387-2017
- Initiated
- September 27, 2016
- Posted by FDA
- November 10, 2016
- Terminated
- July 21, 2017
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 139
- Distribution
- US Nationwide Distribution
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN