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 2 Device Recall Cholestech GDX A1C Test Cartridge

  • 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 2 Device Recall Cholestech GDX A1C Test Cartridgesee related information
Date Initiated by FirmAugust 03, 2006
Date PostedSeptember 23, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall NumberZ-2460-2008
Recall Event ID 49359
510(K)NumberK041635 
Product Classification Cartridge - Product Code LCP
ProductCholestech 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
ActionA 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 Commerce9,324 Cartridges
DistributionU.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
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 = LCP
-
-