BEUDAMED
    FDA Recall Open, Classified

    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

    Recall: Z-0604-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0604-2024
    Event Number
    93349
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    GKZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 19, 2023
    Posted
    December 21, 2023
    Address
    100 Abbott Park Rd, Bldg Ap8b, Abbott Park, IL, 60064-3502

    Description

    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

    Reason

    The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

    Action

    The recalling firm issued the Product Correction letter dated 10/19/2023 via FedEx priority overnight express delivery in the U.S. and either in person or mail, telephone, email, or FAX to the OUS consignees. The product correction is for instruments distributed in the U.S. and Brazil only. The letter explains the issue, lists all products involved (some of which have different 806 report numbers and are being submitted by Division III) and that a precautionary label indicating the presence of dry natural rubber (latex) will be applied to the devices by the local Abbott representative. The Impact to User Safety is provided and actions to be taken by the customer, which included: Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the listed Abbott products; complete and return the Customer Reply Form; if the consignee has forwarded the product(s) listed to other laboratories, inform them of this Product Correction and provide a copy of the letter; and retain this letter for their laboratory records.

    Distribution

    Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Brazil.

    Quantity

    670 devices (329 US and 341 OUS)