| Class 3 Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set |  |
Date Initiated by Firm | June 15, 2009 |
Date Posted | March 05, 2010 |
Recall Status1 |
Terminated 3 on February 02, 2011 |
Recall Number | Z-1013-2010 |
Recall Event ID |
52719 |
510(K)Number | K070452 |
Product Classification |
Assay, glycosylated hemoglobin - Product Code LCP
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Product | Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA |
Code Information |
Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only. |
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 |
Manufacturer Reason for Recall | Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples. |
FDA Determined Cause 2 | Other |
Action | Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information. |
Quantity in Commerce | 613 units |
Distribution | Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, 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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