Date Initiated by Firm |
January 13, 2009 |
Date Posted |
March 31, 2009 |
Recall Status1 |
Terminated 3 on December 09, 2009 |
Recall Number |
Z-1043-2009 |
Recall Event ID |
50821 |
510(K)Number |
K842579
|
Product Classification |
Direct Antigen Candida Spp. Id - Product Code LRF
|
Product |
BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100
Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose. |
Code Information |
Lot #121208, Expiration Date: 2-12-09. |
Recalling Firm/ Manufacturer |
Lexamed 705 Front St Toledo OH 43605-2107
|
For Additional Information Contact |
419-693-5307
|
Manufacturer Reason for Recall |
Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
|
FDA Determined Cause 2 |
Process control |
Action |
The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail aschuler@lexamed.net. |
Quantity in Commerce |
1 vial |
Distribution |
USA: Utah |
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.
|
510(K) Database |
510(K)s with Product Code = LRF and Original Applicant = BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
|