Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall LyfoCults

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall LyfoCultssee related information
Date Initiated by FirmOctober 15, 2007
Date PostedFebruary 15, 2008
Recall Status1 Terminated 3 on April 07, 2011
Recall NumberZ-0721-2008
Recall Event ID 45530
Product Classification Quality Control kit for culture media - Product Code JTR
ProductPML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
Code Information Lot # 233851-1, Catalog # 101364
Recalling Firm/
Manufacturer		 PML, Inc. dba Pml Microbiologicals Inc.
27120 Sw 95th Ave
P.o. Box 570
Wilsonville OR 97070-0570
For Additional Information ContactJeffrey A. Miller
503-570-2517
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
ActionOn 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 Commerce30 packs (each pack contains 5 vials of Haemophilus parainfluenzae)
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
-
-