Z-1013-2010

Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU...

Name: Z-1013-2010 Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU...
Creator: Bio-Rad Laboratories Inc
Published: 2009-06-15
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2009-06-15 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA on 2009-06-15. The reason FDA records is "Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1013-2010
Status: Terminated
Initiated: 2009-06-15
Posted: 2010-03-05
Terminated: 2011-02-02
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information.
Quantity in commerce: 613 units
Distribution: Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
Product codes and lots: Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only.

Product code LCP

K070452Class IIVariant II Hemoglobin A1c Program with Models 270-2101NuBio-Rad Laboratories, Inc. / cleared 2007-05-07

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)