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Class 2 Device Recall Variant II Hemoglobin Testing System with CDM v 4.0 |
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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
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Product Classification |
Glycosylated Hemoglobin Assay - Product Code LCP
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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
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For Additional Information Contact |
510-724-7000
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Manufacturer Reason for Recall |
The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LCP and Original Applicant = BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
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