Z-1041-2009

Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by...

Name: Z-1041-2009 Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by...
Creator: Bio-Rad Laboratories Inc
Published: 2008-10-17
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-10-17 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an... on 2008-10-17. The reason FDA records is "Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1041-2009
Status: Terminated
Initiated: 2008-10-17
Posted: 2009-03-24
Terminated: 2010-11-12
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.
Quantity in commerce: 92 units
Distribution: Worldwide Distribution
Product codes and lots: version 4.0 software

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)