Z-1176-06

Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No...

Name: Z-1176-06 Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No...
Creator: Roche Diagnostics Corp.
Published: 2006-06-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-06-07 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160 on 2006-06-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1176-06
Status: Terminated
Initiated: 2006-06-07
Posted: 2006-06-27
Terminated: 2008-04-23
Recalling firm: Roche Diagnostics GmbH
Product: Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
Product code: CIC Cresolphthalein Complexone, Calcium
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 933 kits
Distribution: Nationwide.
Product codes and lots: Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).

Product code CIC

K041009Class IIRaichem Calcium (Ocpc) Liquid ReagentHemagen Diagnostics, Inc. / cleared 2004-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)