Z-0867-2010

Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc...

Name: Z-0867-2010 Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc...
Creator: Bio-Rad Laboratories Inc
Published: 2009-10-12
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2009-10-12 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent... on 2009-10-12. The reason FDA records is "Product update kit CD rom will not upload. As a result, the device cannot be run". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0867-2010
Status: Terminated
Initiated: 2009-10-12
Posted: 2010-02-26
Terminated: 2010-12-17
Recalling firm: Bio-Rad Laboratories Inc.
Product: Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Product update kit CD rom will not upload. As a result, the device cannot be run.
FDA root cause: Other
Action: The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.
Quantity in commerce: 21 kits
Distribution: Worldwide Distribution -- USA, Hong Kong, and New Zealand.
Product codes and lots: Lot No. 70291520.

Product code LCP

K063400Class IIVariant II Turbo Hemoglobin A1c Program, Hemoglobin Testing System with Cdm 4.0Bio-Rad Laboratories, Inc. / cleared 2006-12-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)