Events

Recall of Device Recall Coulter Preplus 2

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
    57948
  • Event Risk Class
    Class 2
  • Event Number
    Z-1895-2011
  • Event Initiated Date
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97813
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Reason
    The recall was initiated after erroneous, though potentially credible, results due to intermittent reagent level sense failures could be generated. during these failures, the instrument fails to produce a warning that a reagent vial is low or out of reagent. the low or absent levels of reagent used during these failures may lead to insufficient antibody being dispensed into a daughter tube there.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated January 18, 2011 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Follow PrepPlus 2 Instructions for Use (Part # 4277264-BA) for all reagent and specimen requirements prior to initiating a run on the PrepPlus 2 including: A) Ensuring all dead volume requirements for reagents as indicated in 7.11 and 7.12 of the Sample Processing sections and 12.2 of the Troubleshooting Guide. Appropriate volume of reagent in all vials per the planned number of tests to be run must contain at least the volume listed on the Worklist (plus an additional 10% of the full volume of the container to account for dead volume)". B) Ensuring specimen processing dead volume requirements are met as indicated in section B of Specimen Tube Size to ensure the minimum amount of specimen needed. C) Monitoring for any foaming/bubble accumulation in the reagent vial. 2) A review of all clinically relevant results generated from samples prepared on the system be conducted. Abnormally dim or unexpected negative sample staining patterns should be reviewed to ensure correlation with clinical symptomatology and other diagnostic data. If the clinical information Is in accordance with the clinical data released, the validity of the results could be considered accurate and no retrospective action may be needed. If inconsistent data is observed, please adhere to good laboratory practices within your institution and consider data re-analysis and re-testing. The customers were also instructed to share this information with their laboratory staff and retain it as part of their laboratory Quality System documentation; if they have forwarded any of the affected product(s) listed above to another laboratory, provide a copy of the letter to them, and complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM via fax to: (786)639-7500/7501/750

Device

Device Recall Coulter Preplus 2
  • Model / Serial
    Part #378600
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Barbados, Belarus, Belgium, Canada, Croatia, France, Germany, Ireland, Italy, Japan, Malawi, Mozambique, Namibia, Poland, Puerto Rico, Russian Federation, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Ukraine, United Kingdom, Zambia.
  • Product Description
    Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. || PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL.
  • 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