Events

Recall of Device Recall D10 Dual Program Reorder Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59346
  • Event Risk Class
    Class 3
  • Event Number
    Z-2889-2011
  • Event Initiated Date
    2011-07-11
  • Event Date Posted
    2011-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102336
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    Reports of calibration failure and late retention time using elution buffer aa10434 and aa10435.
  • 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

Device

Device Recall D10 Dual Program Reorder Pack
  • Model / Serial
    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
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA