COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
This recall has been terminated (originally issued November 5, 2013).
- Recall Initiated
- September 16, 2013
- Posted
- November 5, 2013
- Terminated
- May 12, 2015
- Recall Number
- Z-0168-2014
- Quantity
- 527 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
Distribution
Nationwide Distribution and Puerto Rico
Lot / Code Info
software version 9864.C2
Root Cause
Software Design Change
Action Taken
Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.