Events

Recall of SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

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
    30362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0262-5
  • Event Initiated Date
    2004-10-25
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35734
  • 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
    Lipase-Esterase, Enzymatic, Photometric, Lipase - Product Code CHI
  • Reason
    Beckman coulter has confirmed that occasionally a cuvette may be skipped during the synchron lipase wash (liwa) procedure. if this occurs, there is the potential for carryover into the synchron lipase (lipa) assay, resulting ina substantial positive bias affecting lipase (lipa) results.
  • Action
    The week of 10/25/2004, a product corrective action (PCA) letter was mailed vis U.S. mail to all customers shipped LIPA reagent for the 24 months preceding the discovery of the issue. Customers instructed to repeat any sample that produces a lipase value of > 170 U/L that cannot be confirmed by patient history.

Device

SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
  • Model / Serial
    Part number: 465101  Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005  M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and Canada
  • Product Description
    SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA