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U.S. Department of Health and Human Services

Class 3 Device Recall VARIANT II TURBO Link Hemoglobin A1c Program

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  Class 3 Device Recall VARIANT II TURBO Link Hemoglobin A1c Program see related information
Date Initiated by Firm July 28, 2011
Date Posted September 06, 2011
Recall Status1 Terminated 3 on November 01, 2011
Recall Number Z-3159-2011
Recall Event ID 59659
510(K)Number K070819  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack.
Calibrator/Diluent Set.
IVD.
Kit components:
Elution Buffer A, 2 x 2500 mL
Elution Buffer B, 1 x 2100 mL
Wash/Diluent Solution, 1 x 2500 mL
Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges;
CD-ROM -
Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water
Whole Blood Primer, 6 x 1 mL
Sample Vials, 2 x 100
Instruction Manual.
Bio-Rad Laboratories Inc. Hercules, CA 94547

Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
Code Information Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive
Hercules CA 94547-1803
For Additional Information Contact Jackie Buckley
510-741-5309
Manufacturer Reason
for Recall		 The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.
FDA Determined
Cause 2		 Employee error
Action The firm, BIO-RAD, sent a "Medical Device Correction" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replacement Elution Buffer B. In addition, the customers were to complete and return the 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 40
Distribution Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
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., CLINICAL SYSTEMS DIVISI
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