Roche Diagnostics Corp. Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
Products Sold
Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
Roche Diagnostics Corp. is recalling Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. due to 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 labeli. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026