BEUDAMED
    FDA Recall Terminated

    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.

    Recall: Z-0653-2014 · Initiated June 3, 2013

    Recall

    Recall Number
    Z-0653-2014
    Event Number
    66870
    Firm
    Alere San Diego, Inc.
    FEI Number
    1000125596
    Product Code
    DKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2013
    Posted
    January 9, 2014
    Terminated
    March 18, 2014
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.

    Reason

    Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.

    Action

    Firm sent customers notification letter via combination of fax, email or direct mail. The notification letter dated June 3, 2013, titled "URGENT PRODUCT SAFETY NOTICE", informed customers of the recall, reason for recall, product description with lot codes, potential hazard statement, customer required actions, and contact information.

    Distribution

    US Distribution: including states of: AL, CA, PA, and VA.

    Quantity

    280,710