Events

Rappel de UniCel Dxl 800 Access lmmunoassay System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Beckman Coulter Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    46336
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1184-2008
  • Date de mise en oeuvre de l'événement
    2007-10-08
  • Date de publication de l'événement
    2008-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67204
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    in vitro diagnostic - Product Code JJE
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    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
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA