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U.S. Department of Health and Human Services

Class 3 Device Recall VARIANT II Link Hemoglobin A1c Program Reorder Pack

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  Class 3 Device Recall VARIANT II Link Hemoglobin A1c Program Reorder Pack see related information
Date Initiated by Firm October 25, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 02, 2012
Recall Number Z-0399-2012
Recall Event ID 60230
510(K)Number K070819  
Product Classification Calibrator, hemoglobin and hematocrit measurement - Product Code KRZ
Product VARIANT II Link Hemoglobin A1c Program Reorder Pack,
1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood.
Contents:
Elution Buffer A , 1 x 2500 mL
Elution Buffer B, 1 x 2100 mL
Wash/Diluent Solution, 1 x 2500 mL
Cartridge Set
CD ROM - 1
Calibrator/Diluent Set
Whole Blood Primer, 6 x 1 mL
Sample vials, 2 x 100
Instruction Manual

Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803.

Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).
Code Information Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive
Hercules CA 94547-1803
For Additional Information Contact Jolene Bartilson
510-741-6114
Manufacturer Reason
for Recall		 It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
FDA Determined
Cause 2		 Process control
Action Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114.
Quantity in Commerce 63
Distribution Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY 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 = KRZ and Original Applicant = BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
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