BEUDAMED
    FDA Recall Terminated

    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)

    Recall: Z-1425-2020 · Initiated August 15, 2019

    Recall

    Recall Number
    Z-1425-2020
    Event Number
    84832
    Firm
    Beckman Coulter Inc
    FEI Number
    2050010
    Product Code
    CIG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 15, 2019
    Terminated
    February 28, 2024
    Address
    2470 Faraday Ave, Carlsbad, CA, 92010-7224

    Description

    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)

    Reason

    It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

    Action

    On August 15, 2019, the firm mailed or emailed a "Urgent Medical device Recall" to affected consignees In addition to informing the consignees about the recall, they ask consignees to do the following: 1. Resolution: The following statement will be added to the Interfering Substances section of the Enzymatic Creatinine, Triglycerides GPO Blanked, Uric Acid, Direct Bilirubin, and Total Bilirubin Chemistry Information Sheets (CIS): N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may generate erroneously low results in samples for patients that have taken toxic doses of acetaminophen (paracetamol). 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 3. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center; " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States and Canada. " Outside the United States and Canada, contact your local Beckman Coulter representative.

    Distribution

    Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas,Utah,Virginia,Washington,West Virginia, Wisconsin,Wyoming Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Curacao, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Guyana, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Netherlands, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam

    Quantity

    17,824 reagents