Events

Recall of Device Recall Synchron System(s) Lactate Reagent

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
    65377
  • Event Risk Class
    Class 2
  • Event Number
    Z-1613-2013
  • Event Initiated Date
    2013-05-28
  • Event Date Posted
    2013-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118738
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • Reason
    Beckman coulter has confirmed customer reports of lact lot m210077 failing calibration with error condition ocr low. the calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). failed calibration of lact may cause a delay in reporting results.
  • Action
    Beckman Coulter Inc. sent an Urgent Product Correction letter dated May 28, 2013 to affected customers. The letter identified the affected product, the issue, impact, actions to be taken, and resolution. The letter instructed customers to discontinue use of the affected product and request a replacement product. For questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call 800-854-3633 in the United States and Canada. Outside the United States or Canada, contact your local Beckman Coulter Representative.

Device

Device Recall Synchron System(s) Lactate Reagent
  • Model / Serial
    Part Number A95550, Lot Number M210077
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and country of Canada.
  • Product Description
    SYNCHRON System(s) Lactate (LACT) Reagent. || Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA