Z-1824-2011

Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation...

Name: Z-1824-2011 Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation...
Creator: Roche Diagnostics Operations, Inc.
Published: 2010-10-11
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2010-10-11 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative... on 2010-10-11. The reason FDA records is "Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1824-2011
Status: Terminated
Initiated: 2010-10-11
Posted: 2011-03-25
Terminated: 2011-09-13
Recalling firm: Roche Diagnostics GmbH
Product: Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.
Product code: CIC Cresolphthalein Complexone, Calcium
Reason for recall: Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations revealed the presence of precipitate in the R2 of the affected calcium reagent lots. The precipitate observed was classified as o-cresolphthalein complexone (o-CPC), a reactive component of the calcium R2. The root cau
FDA root cause: Other
Action: The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
Quantity in commerce: 14,528 units
Distribution: Nationwide distribution.
Product codes and lots: 62602201

Product code CIC

K963292Class IICobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. / cleared 1996-10-31

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)