| Class 2 Device Recall cobas c 311 Analyzer | |
Date Initiated by Firm | October 26, 2011 |
Date Posted | November 30, 2011 |
Recall Status1 |
Terminated 3 on July 09, 2012 |
Recall Number | Z-0310-2012 |
Recall Event ID |
60282 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Operations, Inc. 9115 Hague Road Indianapolis IN 46256-1025
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For Additional Information Contact | Betsy Cox 317-576-2000 Ext. 249 |
Manufacturer 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 2 | Software design |
Action | 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. |
Quantity in Commerce | 940 worldwide |
Distribution | Worldwide Distribution -- USA including the states of Maryland and Texas. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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