Recall Z-0542-2009 ยท JIX Calibrator, Multi-Analyte Mixture
Roche Diagnostics Corp.
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
| Date | Jan 6, 2009 (initiated Sep 15, 2008) |
| Status | Terminated |
| Reason | Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336. |
| Root cause | Package design/selection |
| Action | Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336. |
| Quantity | 7909 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060373 | COBAS 6000 SERIES SYSTEM Roche Diagnostics, Mar 13, 2006 |