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U.S. Department of Health and Human Services

Class 2 Device Recall Variant II Turbo Hemoglobin A1C Program

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  Class 2 Device Recall Variant II Turbo Hemoglobin A1C Program see related information
Date Initiated by Firm October 12, 2009
Date Posted February 26, 2010
Recall Status1 Terminated 3 on December 17, 2010
Recall Number Z-0867-2010
Recall Event ID 53649
510(K)Number K063400  
Product Classification Glycosylated Hemoglobin Assay - Product Code LCP
Product Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA.

Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
Code Information Lot No. 70291520.
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		 Product update kit CD rom will not upload. As a result, the device cannot be run.
FDA Determined
Cause 2		 Other
Action The firm initiated this action on 10/12/2009. Consignees were contacted by phone with a fax follow up. Subsidiaries, as well as consignees that received the product, were provided with a Medical Device Correction notice, dated October 13, 2009, and response form. Each subsidiary will contact customers. The letter asks customers to destroy the affected lot included with their reorder packs and replace them with the lot number that's enclosed. Customers are to complete the Customer Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs Department at the number provided. Questions should be directed to customers' regional Bio-Rad office.
Quantity in Commerce 21 kits
Distribution Worldwide Distribution -- USA, Hong Kong, 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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