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U.S. Department of Health and Human Services

Class 3 Device Recall D10 Hemoglobin A1c Program Elution Buffer 2:

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  Class 3 Device Recall D10 Hemoglobin A1c Program Elution Buffer 2: see related information
Date Initiated by Firm September 12, 2011
Date Posted October 07, 2011
Recall Status1 Terminated 3 on May 11, 2012
Recall Number Z-0019-2012
Recall Event ID 59868
510(K)Number K031043  
Product Classification Assay, glycoslylated hemoglobin - Product Code LCP
Product D-10 Hemoglobin A1c Program Elution Buffer 2:

Bio-Rad Laboratories, Hercules, CA 94547.

Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Code Information Model number: 220-0211; Lot number AA10441, expiry 2/28/13; Lot number AA10889, expiry 3/31/13. 
Recalling Firm/
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive
Hercules CA 94547-1803
For Additional Information Contact Jackie Buckley
Manufacturer Reason
for Recall
A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
FDA Determined
Cause 2
Process control
Action Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product. Customers were asked to please translate (if necessary) the attached "Customer Medical Device Correction Response Form," customers should add their local contact information and distribute to all affected customers in their region by mail or fax. Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter. Complete the "SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD. Customers would be issued credits for the affected products based on their request. For questions call (510) 741-3954.
Distribution Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
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.