Z-1902-2010

VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600...

Name: Z-1902-2010 VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600...
Creator: Bio-Rad Laboratories Inc
Published: 2009-01-22
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2009-01-22 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories Inc began a recall of VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad... on 2009-01-22. The reason FDA records is "Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1902-2010
Status: Terminated
Initiated: 2009-01-22
Posted: 2010-06-25
Terminated: 2011-03-22
Recalling firm: Bio-Rad Laboratories Inc.
Product: VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
Root cause tag: software
FDA root cause: Software design
Action: Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.
Distribution: Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.
Product codes and lots: All units of these models.

Product code LCP

K984268Class IIVariant II Hemoglobin A1c ProgramBio-Rad / cleared 1998-12-17

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)