| Class 2 Device Recall VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5 |  |
Date Initiated by Firm | January 22, 2009 |
Date Posted | June 25, 2010 |
Recall Status1 |
Terminated 3 on March 22, 2011 |
Recall Number | Z-1902-2010 |
Recall Event ID |
51498 |
510(K)Number | K984268 |
Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
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Product | VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.
Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood. |
Code Information |
All units of these models. |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories Inc 4000 Alfred Nobel Dr Hercules CA 94547-1803
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For Additional Information Contact | Jackie Buckley 510-724-7000 |
Manufacturer Reason for Recall | Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position. |
FDA Determined Cause 2 | Software design |
Action | Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution.
For further information, contact Bio-Rad Laboratories at 1-510-724-7000. |
Distribution | Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom. |
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
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