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U.S. Department of Health and Human Services

Class 3 Device Recall BEC Growth Chek Microbial Suspension Candida albicans CA1 (100 dose)

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 Class 3 Device Recall BEC Growth Chek Microbial Suspension Candida albicans CA1 (100 dose)see related information
Date Initiated by FirmJanuary 13, 2009
Date PostedMarch 31, 2009
Recall Status1 Terminated 3 on December 09, 2009
Recall NumberZ-1043-2009
Recall Event ID 50821
510(K)NumberK842579 
Product Classification Direct Antigen Candida Spp. Id - Product Code LRF
ProductBEC 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.
FEI Number 1525897
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
ActionThe 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 Commerce1 vial
DistributionUSA: Utah
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.
510(K) Database510(K)s with Product Code = LRF
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