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U.S. Department of Health and Human Services

Class 2 Device Recall Variant II Hemoglobin Testing System with CDM v 4.0

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  Class 2 Device Recall Variant II Hemoglobin Testing System with CDM v 4.0 see related information
Date Initiated by Firm December 09, 2008
Date Posted May 19, 2009
Recall Status1 Terminated 3 on November 12, 2010
Recall Number Z-1395-2009
Recall Event ID 50531
510(K)Number K063643  
Product Classification Glycosylated Hemoglobin Assay - Product Code LCP
Product Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA

Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Code Information CDM version 4.0 software
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 wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
FDA Determined
Cause 2		 Pending
Action Recall initiated on December 10, 2008. Notification conducted by phone call and fax for domestic consignees. Each subsidiary will receive the subsidiary Urgent: Medical Device Correction notice, customer medical device correction response form and number of customers distributed to by e-mail. Each subsidiary must contact customers and provide the customer notice and response form as needed. The notice stated that Bio-Rad Laboratories would release a follow up communication providing a permanent solution upon completion of an investigation. In the interim, it was recommended that customers carefully review the Summary Report for duplicate barcode IDs or or tube position numbers within the same rack. If there are any questions or assistance needed, the local regional Bio-Rad office should be contacted.
Quantity in Commerce 42 units
Distribution Worldwide Distribution -- USA, Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK.
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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