BEUDAMED
    FDA Recall Terminated

    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

    Recall: Z-2084-2017 · Initiated April 3, 2017

    Recall

    Recall Number
    Z-2084-2017
    Event Number
    76962
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DKJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 3, 2017
    Terminated
    May 31, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

    Reason

    Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

    Action

    An Urgent Medical Device Recall letter dated 4/3/17 was sent to customers to inform them that Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole, Sulfasalazine, and Sulfapyridine. Customers are informed that with the administration of these drugs, the effects to patient analytes are: - Metamizole (Dipyrone) may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results. -Sulfasalazine may generate false high Salicylate results. -Sulfapyridine may generate false low Salicylate results. Customers are informed of the action and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center -Via http://www.beckmancoulter.com/customersupport/support -Via phone, call 1-800-854-3633 in the United States and Canada Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.

    Quantity

    50,645 units total (43,816 units in US)