Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
FDA device recall Z-1176-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CIC
- Quantity affected
- 933 kits
- Distribution
- Nationwide.
- Date initiated
- 2006-06-07
- Date posted
- 2006-06-27
- Date terminated
- 2008-04-23
- Location
- Indianapolis, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009) | Hemagen Diagnostics, Inc. | 2004-06-25 |