BEUDAMED
    FDA Recall Terminated

    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    Recall: Z-0723-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-0723-2008
    Event Number
    45530
    Firm
    PML, Inc. dba Pml Microbiologicals Inc.
    FEI Number
    3017344
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 15, 2007
    Posted
    February 15, 2008
    Terminated
    April 7, 2011
    Address
    27120 Sw 95th Ave P.o. Box 570, Wilsonville, OR, 97070-0570

    Description

    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    Reason

    Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

    Action

    On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.

    Distribution

    Nationwide Distribution

    Quantity

    5 kits. Each kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) for a total of 25 vials.