Events

Recall of Device Recall Abbott

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

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
    25503
  • Event Risk Class
    Class 2
  • Event Number
    Z-0632-03
  • Event Initiated Date
    2003-01-10
  • Event Date Posted
    2003-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25937
  • 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
    Mixture, Hematology Quality Control - Product Code JPK
  • Reason
    Product may elicit fluorescent signal interference due to bacterial contamination.
  • Action
    On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device.

Device

Device Recall Abbott
  • Model / Serial
    All lots of 9402212 and ALL lower numbers.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts include: Argentina, Canada and Puerto Rico. Product was distributed to 10 U.S. Government accounts: (1) AK Native Med Center Supply 4315 Diplomacy Dr. Anchorage, AK 99508 907-729-1200 (2) Walter Reed Army Medical 6900 georgia Ave. NW Washington DC 20307 202-782-2579 (3) WHMC Medical material Mgr. 2200 Bergquest Dr. lackland AFB, TX 78236 (210)-670-7505 (4) DD Eisenhower AMC PAT E. Hospital Rd. Fort Gorden, GA 80220 (706) 791-2430 (5) VA Medical Center 1055 Claremont St. Denver, CO 80220 (303) 399-8020 (6) VA Hospital Supply 500 Foothill Dr. Salt Lake City, UT 84148 (801) 584-1248 (7) WHMC Medical Material Mgr. 2200 Bergquist Dr. Lackland AFB, TX 78236 (210) 670-7505 (8) VA Medical Center 650 E. Indian School Rd. Phoenix, AZ 85012 (602) 277-5551 (9) VA Medical Center 109 Bee St. Charleston, SC 29401 (843) 577-5011 (10) USPHS Phoenix 4212 N. 16th St. Phoenix, AZ 85016 (602) 263-1585
  • Product Description
    Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System || CELL-DYN REAGENT PART A || Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Drive, Santa Clara CA 95054
  • Source
    USFDA