Events

Recall of Device Recall Beckman Coulter HbA1c APT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    58168
  • Event Risk Class
    Class 2
  • Event Number
    Z-2170-2011
  • Event Initiated Date
    2011-03-01
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98572
  • 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, glycoslylated hemoglobin - Product Code LCP
  • Reason
    The recall was initiated because beckman coulter has identified a problem with two lots of hba1c apt reagent osr61177. when hba1c apt reagent lots 9390 and 9472 are calibrated with hba1c calibrator odr3032, elevated recovery may be observed for patient samples. falsely elevated hba1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. consequent medical acti.
  • Action
    Beckman Coulter initiated the recall communication with a Product Corrective Action (PCA) letter with attached recall response form on March 1, 2011 to the affected customers. The letter explained the problem and identified the action to be taken. The PCA also instructed the consignees to: (1) Please discontinue the use of lots 9390 and 9472 and discard according to your local procedures. (2) Please contact your local Beckman Coulter support Organization for replacement reagent. (3) You may need to re-evaluate samples for HbA1c which were tested with either of the listed lots of reagent. In addition, customers were instructed to: (1) share the information with their laboratory staff and retain this notification as part of their Quality System documentation. If any of the affected product was forwarded to another laboratory, a copy of the letter should be provided to them. (2) complete and return the enclosed response form within 10 days so that the firm was assured the customer received the important communication. For any questions regarding this notice, customers were instructed to contact Customer Technical Support at 1-800-854-3633 in the U.S.A and at 00353656831111 in Europe.

Device

Device Recall Beckman Coulter HbA1c APT
  • Model / Serial
    Lot Numbers: 9390 & 9472
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam.
  • Product Description
    Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 || Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA