Z-0649-05

Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog...

Name: Z-0649-05 Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog...
Creator: Roche Diagnostics Corp.
Published: 2005-02-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-02-15 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322 on 2005-02-15. The reason FDA records is "The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0649-05
Status: Terminated
Initiated: 2005-02-15
Posted: 2005-03-23
Terminated: 2005-05-17
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
FDA root cause: Other
Action: Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
Quantity in commerce: 347,000 cassettes
Distribution: Nationwide.
Product codes and lots: Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153, 650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104.

Product code LCP

K003120Class IIModification to Integra Reagent Cassette for Hemoglobin A1cRoche Diagnostics Corp. / cleared 2000-12-18

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)