Events

Recall of Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set

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
    37363
  • Event Risk Class
    Class 3
  • Event Number
    Z-0595-2007
  • Event Initiated Date
    2006-12-22
  • Event Date Posted
    2007-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50418
  • 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 MVU
  • Reason
    The lsi d13s319 so/13q34 sa/cep 12 sg probe of the two mixture dna-probe was contaminated with lsi atm sg/p53 so probe. this contamination would result in 10 fish signals in each normal cell rather than the expected 6 fish signals in each normal cell.
  • Action
    Abbott Molecular telephoned and/or sent recall letters to the Abbott FISH accounts on 12/22/06, advising them that an unexpected signal pattern with the Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 Probe was observed, confirmed and identified as a result of contamination in a subset of vials of D13S319 /CEP 12/13q34 from lot number 79500. This contamination results in 10 FISH signals in each normal cell (4 SO, 4 SG, 2 SA) rather than the expected 6 FISH signals in each normal cell (2 SO, 2 SG, 2 SA). The customers were advised that lot 80178 was also being included in the recall, and were requested to review the information carefully and assess the risk to their patient population; discontinue and destroy any unused product immediately; complete and return the enclosed reply form; review the information with laboratory personnel; and communicate the information to health care providers served in cases where the affected product were used and reported. Abbott Molecular provided replacement product for that product destroyed, upon receipt of the reply form. Any questions were directed to Abbott Molecular Technical Service at 800-553-7042, option 2.

Device

Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set
  • Model / Serial
    list 05J83-001, part number 32-191025, lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.
  • Product Description
    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; || The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
  • Manufacturer
    Abbott Molecular

Manufacturer

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