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U.S. Department of Health and Human Services

Class 2 Device Recall Variant II Turbo

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  Class 2 Device Recall Variant II Turbo see related information
Date Initiated by Firm December 08, 2009
Date Posted April 06, 2011
Recall Status1 Terminated 3 on June 29, 2011
Recall Number Z-1898-2011
Recall Event ID 54684
510(K)Number K063400  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***"

Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
Code Information Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010  
Recalling Firm/
Manufacturer
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jackie Buckley
510-724-7000
Manufacturer Reason
for Recall
Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.
FDA Determined
Cause 2
Other
Action The firm, Bio-Rad, sent a "MEDICAL DEVICE CORRECTION" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter. 2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert. 3) Complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to: Bio-Rad CSD Regulatory Affairs Department at (510) 741-3954. If you have any questions, please call 510-724-7000 or contact your regional Bio-Rad office.
Quantity in Commerce 51 kits (Lot # 70292242; 45 kits( Lot # 70292318)
Distribution Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.
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 and Original Applicant = BIO-RAD LABORATORIES, INC.
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