Z-1259-2011

Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600...

Name: Z-1259-2011 Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600...
Creator: Bio-Rad Laboratories Inc
Published: 2010-02-19
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-02-19 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set... on 2010-02-19. The reason FDA records is "The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results". 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-1259-2011
Status: Terminated
Initiated: 2010-02-19
Posted: 2011-02-15
Terminated: 2011-03-03
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Box, Instruction Manual and Quick Guide Intended use: Measurement of Hemoglobin A1c in human whole blood.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Bio-Rad Laboratories, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.
Quantity in commerce: 27
Distribution: Worldwide distribution: USA including states of: OH, MN, SC and VA; and country including: Japan.
Product codes and lots: Catalog No. 270-2716 Lot No. 70291030, expiration date 2/28/2010 Lot No. 70392119, expiration date 3/31/2010 Lot No. 70292119R, expiration date 3/31/2010

Product code LCP

K070819Class IIVariant II Turbo Link Hemoglobin A1c Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,Bio-Rad Laboratories Inc., Clinical Systems Divisi / cleared 2007-06-25

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)