Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
FDA Recall Z-1176-06 · Posted 2006-06-27
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCIC
Date Initiated2006-06-07
Date Terminated2008-04-23
Product Quantity933 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.