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U.S. Department of Health and Human Services

Class 2 Device Recall Cholestech GDX A1C Test Cartridge

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  Class 2 Device Recall Cholestech GDX A1C Test Cartridge see related information
Date Initiated by Firm August 03, 2006
Date Posted September 23, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-2460-2008
Recall Event ID 49359
510(K)Number K041635  
Product Classification Cartridge - Product Code LCP
Product Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
Code Information Catalog #12-658, Lot #066T28
Recalling Firm/
Manufacturer		 Cholestech Corp
3347 Investment Blvd
Hayward CA 94545-3808
For Additional Information Contact
510-781-3505
Manufacturer Reason
for Recall		 Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.
Quantity in Commerce 9,324 Cartridges
Distribution U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
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 = LCP and Original Applicant = PROVALIS DIAGNOSTICS LTD.
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