Events

Recall of LyfoCults (IDS Rapid NH QC Set)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PML, Inc. dba Pml Microbiologicals Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45530
  • Event Risk Class
    Class 3
  • Event Number
    Z-0723-2008
  • Event Initiated Date
    2007-10-15
  • Event Date Posted
    2008-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66395
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Quality Control kit for culture media - Product Code JTR
  • 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.

Device

LyfoCults (IDS Rapid NH QC Set)
  • Model / Serial
    Lot # 134-1, Catalog # 201155 - IDS Rapid NHQC Set; Lot # 233851-1, Catalog #101364 - LyfoCults Microorganism
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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
  • Manufacturer
    PML, Inc. dba Pml Microbiologicals Inc.

Manufacturer

PML, Inc. dba Pml Microbiologicals Inc.
  • Manufacturer Address
    PML, Inc. dba Pml Microbiologicals Inc., 27120 Sw 95th Ave, P.o. Box 570, Wilsonville OR 97070-0570
  • Manufacturer Parent Company (2017)
    Pml Microbiologicals Inc.
  • Source
    USFDA