Z-1395-2009

Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad...

Name: Z-1395-2009 Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad...
Creator: Bio-Rad Laboratories Inc
Published: 2008-12-09
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-12-09 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent... on 2008-12-09. The reason FDA records is "The wrong barcode number and tube position number may be assigned to samples 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-1395-2009
Status: Terminated
Initiated: 2008-12-09
Posted: 2009-05-19
Terminated: 2010-11-12
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers carefully review the Summary Report for duplicate barcode IDs or or tube position numbers within the same rack. If there are any questions or assistance needed, the local regional Bio-Rad office should be contacted.
Quantity in commerce: 42 units
Distribution: Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK.
Product codes and lots: CDM version 4.0 software

Product code LCP

K063643Class IIModification to Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program and Total Ghb ProgramBio-Rad Laboratories Inc., Clinical Systems Divisi / cleared 2006-12-27

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)