BEUDAMED
    FDA Recall Terminated

    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

    Recall: Z-0636-2022 · Initiated March 2, 2017

    Recall

    Recall Number
    Z-0636-2022
    Event Number
    89412
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 2, 2017
    Terminated
    April 22, 2022
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

    Reason

    Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

    Action

    Microbiologics notified customers on about 03/02/2017, via letter titled "Medical Device Recall." Customers were instructed to: 1. DO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory. 2. QUARANTINE or DISCARD the product to prevent further use. 3. RETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box Attention: Technical Manager. 4. Acknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to [email protected] or by faxing to 320.253.6250.

    Distribution

    International distribution in the countries of Canada and Germany.

    Quantity

    2 units