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U.S. Department of Health and Human Services

Class 3 Device Recall VARIANT II TURBO Hemoglobin A1c Program

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  Class 3 Device Recall VARIANT II TURBO Hemoglobin A1c Program see related information
Date Initiated by Firm March 24, 2010
Date Posted February 17, 2011
Recall Status1 Terminated 3 on March 04, 2011
Recall Number Z-1342-2011
Recall Event ID 56387
510(K)Number K063400  K040872  
Product Classification Glycosylated Hemoglobin Assay - Product Code LCP
Product Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA.

Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

Code Information Lot Numbers: 70200185.   Lot Nos.: 70200185, AA00190   
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 firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
FDA Determined
Cause 2		 Other
Action Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.
Quantity in Commerce 48 units
Distribution Worldwide Distribution -- USA and Italy.
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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