Class 2 Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System

• Date Initiated by Firm: February 19, 2010
• Date Posted: February 15, 2011
• Recall Status: Terminated on March 03, 2011
• Recall Number: Z-1259-2011
• Recall Event ID: 54746
• 510(K)Number: K070819
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories Inc; 4000 Alfred Nobel Dr; Hercules CA 94547-1803
• For Additional Information Contact: 510-724-7000
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LCP