Recall of 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (hgb) test results.
  • Action
    On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall. In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot.


  • Model / Serial
    (List Number On the Box---List Number On the bottle---Lot Number):  99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2;  08H17-01---08H17-02---16823I2;  08H17-01---08H17-02---17906I2;  08H17-01---08H17-02---17907I2;  08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2;  08H17-01---08H17-02---19296I2;  08H17-01---08H17-02---20413I2;  08H17-01---08H17-02---21540I2;  08H17-01---08H17-02---22739I2;  08H17-01---08H17-02---23889I2    Expanded: All lots under recall.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.
  • Product Description
    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, || List Numbers: || 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); || Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054
  • Manufacturer


  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source