Date Initiated by Firm |
October 15, 2007 |
Date Posted |
February 15, 2008 |
Recall Status1 |
Terminated 3 on April 07, 2011 |
Recall Number |
Z-0722-2008 |
Recall Event ID |
45530 |
Product Classification |
Quality Control kit for culture media - Product Code JTR
|
Product |
PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070 |
Code Information |
Lot # 185-1, Catalog # 201130 - Vitek NH ID Card (HHI) Set; Lot # 233851-1, Catalog # 101364 - LyfoCults Microorganism |
Recalling Firm/ Manufacturer |
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 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 |
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 |
1 kit. Kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae) |
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.
|