Z-0650-05

Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322

Name: Z-0650-05 Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322
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 ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322 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-0650-05
Status: Terminated
Initiated: 2005-02-15
Posted: 2005-03-23
Terminated: 2005-05-17
Recalling firm: Roche Diagnostics GmbH
Product: Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
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: 1800 kits.
Distribution: Nationwide.
Product codes and lots: Lots 646340, 650984, 651640 and 653292.

Product code LCP

K952337Class IIRoche Unimate 3/Unimate 5 Hba1c, Hba1c Calibrator, Hba1c Controls N & PRoche Diagnostic Systems, Inc. / cleared 1996-02-09

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)