Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
Hazard
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.
What You Should Do
Remedy
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.
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Products
Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
- Brand
- Roche Diagnostics Corp.
- UPC
- Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
Units Affected
933 kits