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U.S. Department of Health and Human Services

Class 3 Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set

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  Class 3 Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set see related information
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
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
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
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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