Events

Recall of Device Recall VP 2000 Processor Heated Reagent Basins

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Molecular.

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
    56284
  • Event Risk Class
    Class 2
  • Event Number
    Z-2313-2010
  • Event Initiated Date
    2010-07-20
  • Event Date Posted
    2010-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93138
  • 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
    Automated Slide Stainer - Product Code KPA
  • Reason
    The vp2000 processor heated reagent basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
  • Action
    Abbott sent Urgent Product Recall letters dated 7/20/10 to the VP 2000 Processor customers on same date via FedEx, informing them that the heated reagent basins could crack along the bottom seam, have non-uniform coating of interior corners, warping of the aluminum housing or incorrect dimensions. These deficiencies could result in leakage or the inability to place the basins into the VP 2000 Processor, resulting in possible exposure to chemical reagents, a slippery floor hazard, and/or delay or failure to start a protocol run. An Abbott Molecular customer service representative will call them to coordinate replacement of all of their heated reagent basins before 10/31/10. Customers were to complete and return the Customer Reply form provided. Any questions were directed to their local Abbott Molecular Representative. *** A second recall letter was sent to all customers on 12/21/10 explaining that the VP 2000 heated reagent basins previously inspected and determined to be acceptable could develop a leak, and that they would be contacted by an Abbott Molecular Customer Service Representative or Field Service representative in early 2011 to coordinate replacement of all of their VP 2000 heated reagent basins. ***

Device

Device Recall VP 2000 Processor Heated Reagent Basins
  • Model / Serial
    All basins distributed since September 2008.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, and the United States.
  • Product Description
    VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: || a) list 02J11-013, part number 30-144152 (replacement basins); || b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); || c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); || d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); || Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA