BEUDAMED
    FDA Recall Terminated

    iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.

    Recall: Z-0649-2016 · Initiated December 8, 2014

    Recall

    Recall Number
    Z-0649-2016
    Event Number
    72925
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JIL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 8, 2014
    Terminated
    January 13, 2016
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.

    Reason

    Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.

    Action

    An "Important Product Notice," dated 12/8/14 was sent to customers to inform them of the recall by Iris International. The recall letter informs customers that The identified lots of iChem 10 SG Urine Chemistry Strips may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells (WBCs) /microliter. The letter provides the impact of the recall and the actions to taken by the customers. Customers are instructed to discard any remaining strips from the affected lots and use another lot number. Customers can either contact their local Customer Service Support or complete and return the Replacement Order form, if replacement product is needed. The enclosed response form should be completed and returned within 10 days. Customers with questions are instructed to refer to http://www.beckmancoulter.com; (800) 854-3633 in US and Canada. Customers outside the US and Canada are instructed to contact their local support representative.

    Distribution

    Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.

    Quantity

    16,206 vials total (7,827 vials in US)