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U.S. Department of Health and Human Services

Class 3 Device Recall D10 Dual Program Reorder Pack

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  Class 3 Device Recall D10 Dual Program Reorder Pack see related information
Date Initiated by Firm July 11, 2011
Date Posted July 27, 2011
Recall Status1 Terminated 3 on March 12, 2012
Recall Number Z-2889-2011
Recall Event ID 59346
510(K)Number K041444  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product D-10 Dual Program Reorder Pack;
contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2.
Bio-Rad Laboratories Inc. Hercules, CA.

Product Usage:

Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use.
Code Information Model number 220-0201; Kit Lot number/Expiration date: 20010663/Sept 2012; 20010665-A/Sept 2012; 20010665-B/Sept 2012; 20010665-C/Sept 2012.  Elution Buffer Lot numbers: AA10434, AA10435; Exp 9/30/2012
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jackie Buckley
Manufacturer Reason
for Recall
Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.
FDA Determined
Cause 2
Action Bio-Rad Laboratories Inc sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected D-10 Dual customers and Bio-Rad subsidiaries on July 11, 2011 via FedEx or fax. The letters identified the product, the problem, and the action needed to be taken. The letters ask that inventory be examined and affected reorder pack lots be quarantined and destroyed according to local, state and federal regulations. All D-10 Dual customers were instructed to review their chromatograms generated from these lots. If the calibration has passed with good chromatography, the controls are within specification, and the F, A1c, and A2 peaks elute in their specified retention time windows for the patient samples, the customer may continue to use and report results with the affected buffer lots. The letters include a chart showing Good Patient Chromatogram with Correct Retention times and Failed Calibrator Chromatogram with late retention times. If calibration fails and/or late retention times cause one or more peaks to be misidentified, affected reorder packs should be destroyed. The correction letters and response form should be translated, if necessary, and distributed to all affected customers. Tracking documentation should be compiled for all customers who receive the Medical Device Correction letter. The Medical Device Correction Response Forms should be completed and returned by fax to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or a PDF copy to Jackie_Buckley@bio-rad.com
Quantity in Commerce 418
Distribution Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. 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.