Recall Z-1176-06 ยท CIC Cresolphthalein Complexone, Calcium
Roche Diagnostics Corp.
Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
| Date | Jun 27, 2006 (initiated Jun 7, 2006) |
| Status | Terminated |
| Reason | Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers. |
| Quantity | 933 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT Hemagen Diagnostics, Inc., Jun 25, 2004 |