Events

Recall of UniCel Dxl 800 Access lmmunoassay System

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
    46336
  • Event Risk Class
    Class 2
  • Event Number
    Z-1184-2008
  • Event Initiated Date
    2007-10-08
  • Event Date Posted
    2008-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67204
  • 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
    in vitro diagnostic - Product Code JJE
  • Reason
    Incorrect results: there is an increased variance in assay performance when the unicel dxl 800 modification (mod id 10027) and/or unicel dxl 800 modification (mod id 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿c and 32¿c operating range.
  • Action
    Beckman Coulter mailed a Product Corrective Action (PCA) letter the week of October 8, 2007 to the customers who have the affected UniCel Dxl 800 Access lmmunoassay systems advising that there is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿C and 32¿C operating range. The letter further advises that Beckman Coulter will contact the customer to arrange a date to remove the modificatlons but until the modification is completed, the system should be operated in a room temperature of 20¿C to 30¿C. This can be acomplished by monitoring and recording room tamperature in the area of the instrument. Customers are also asked to review historical quality control records to ensure assay performance is within their laboratory specification and that patient results should be reviewed in context of other diagnostics tests and the clinical presentations of the patient. A response form is included.

Device

UniCel Dxl 800 Access lmmunoassay System
  • Model / Serial
    Part Number 973100; Serial Numbers: 600469, 601097, 601098, 601144, 601182, 601160, 601188, 601071, 601117, 601114, 601137, 601059, 601039, 601099, 601088, 601176, 601184, 601178, 601025, 601186, 601110, 601063, 601002, 601029, 601133, 601106, 601215, 601159, 601077, 601202, 601206, 601079, 601051, 601179, 601130, 601058, 601031, 601212, 601173, 601028, 601078, 601094, 601210, 601189, 601228, 601043, 601092, 601171, 601026, 601122, 601208, 601103, 601089, 601108, 601183, 600933 600971, 600919, 600910, 600904, 600935, 601005, 600977, 600936, 600993, 600965, 601011, 600957, 600918, 601015, 600992, 600905, 600914, 600947, 601016, 601013, 600981, 600903, 600949, 601012, 600983, 600970, 600912, 601004, 600915, 600907, 600987, 600939, 600996, 601007, 600899, 601006, 600938, 600952, 600988, 601020, 600928, 600937, 600972, 955056, 965059, 954609, 949471, 954490, 501442, and 499300.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Beckman Coulter UniCel Dxl 800 Access Immunoassay System; || Part Number: 973100 || With: UniCel Dxl 800 Modification (MOD ID 10027) || and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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