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U.S. Department of Health and Human Services

Class 3 Device Recall LyfoCults (IDS Rapid NH QC Set)

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  Class 3 Device Recall LyfoCults (IDS Rapid NH QC Set) see related information
Date Initiated by Firm October 15, 2007
Date Posted February 15, 2008
Recall Status1 Terminated 3 on April 07, 2011
Recall Number Z-0723-2008
Recall Event ID 45530
Product Classification Quality Control kit for culture media - Product Code JTR
Product 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
Code Information Lot # 134-1, Catalog # 201155 - IDS Rapid NHQC Set; Lot # 233851-1, Catalog #101364 - LyfoCults Microorganism
Recalling Firm/
PML, Inc. dba Pml Microbiologicals Inc.
27120 Sw 95th Ave
P.o. Box 570
Wilsonville OR 97070-0570
For Additional Information Contact Jeffrey A. Miller
Manufacturer Reason
for Recall
Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).
FDA Determined
Cause 2
Mixed-up of materials/components
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.
Quantity in Commerce 5 kits. Each kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) for a total of 25 vials.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.