Recall Z-0310-2012
Roche Diagnostics Operations, Inc. · initiated October 26, 2011
Product
cobas c 311 Analyzer, Part Number: 04826876001 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: Serial Numbers:1050-16, 1040-08, 1041-06, 0927-16, 0918-05, 1048-02, 0812-12, 1058-09, 0925-20, 1044-19, 1041-05, 1043-15, 1056-18, 0812-09, 1038-07, 0814-10, 1041-19, 1170-04, 0929-08, 0919-16, 0814-03, 0926-11, 1035-01, 1034-19, 1035-10, 1174-19, 1176-03, 1067-02, 0919-17, 0920-05, 0927-13, 1060-17, 1060-05, 0927-17, 1044-18, 0812-10, 0811-20, 1041-20, 1174-04, 0925-05, 1060-01, 1062-09, 1066-20, 1174-07, 0814-15, 0814-17, 1053-16, 1054-02, 1034-02, 1052-16, 1052-19, 0918-06, 1052-13, 1052-20, 1052-15, 1034-07, 1043-10, 0811-15, 1054-03, 1061-08, 1043-06, 0926-10, 1044-06, 1034-03, 1052-09, 1043-12, 1055-01, 0929-09, 1038-05, 1034-01, 0810-19, 1054-20, 1062-07, 1059-20, 0814-16, 1043-14, 1062-08, 1054-01, 0929-07, 1038-06, 1056-19, 1057-03, 1169-20, 0926-19, 1067-01, 1038-04, 0925-06, 1043-08, 1043-13, 0812-11, 1057-05, 1060-06, 0926-16, and 1034-06.
Reason for recall
The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.
FDA-determined cause: Software design
Action taken
October 26, 2011 Urgent Medical Device Corrections were sent to all direct accounts in the USA that have installed the cobas c 311 analyzer and included a faxback form to be completed and faxed to 1-877-766-7452. Consignees were instructed to temporarily replace the ISE Reference Electrolyte bottle based upon the frequency calculated from the maximum number of ISE samples run per day and activate the yellow threshold alarm on the system. Customers with question and concerns are directed to call Roche Diagnostics Technical Support at 1-800-428-2366, available 24-hours, 7 days a week.
Details
- Recall number
- Z-0310-2012
- Initiated
- October 26, 2011
- Posted by FDA
- November 30, 2011
- Terminated
- July 9, 2012
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 940 worldwide
- Distribution
- Worldwide Distribution -- USA including the states of Maryland and Texas.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN