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U.S. Department of Health and Human Services

Class 2 Device Recall Alere Cholestech LDX ALT AST Test Cassette

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 Class 2 Recall
Alere Cholestech LDX ALT AST Test Cassette
see related information
Date Posted April 17, 2013
Recall Status1 Terminated on August 13, 2013
Recall Number Z-1139-2013
Recall Event ID 64671
Premarket Notification
510(K) Numbers
K032027  K991834 
Product Classification Hydrazone Colorimetry, Alt/Sgpt - Product Code CKD
Product Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Code Information Lot/Unit Codes: 274351A, 274351B, 274352B, 274353A, 290243A, 290244A, 290641A, 290641B, 290642A, 290643A, 290643B, 290644A, 290644B, 290645A, 290645B, 290646A, 290647A, 290648A, 293669A, 293670A, 293671A, 293672A, 293673A, 296635A, 296636A, 296637A, 296638A, 296639A, 296639B, 296640A, 296641A, 296642A, 297311B, 297313A, 297313B.
Recalling Firm/
Manufacturer
Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego, California 92121-2997
Manufacturer Reason
for Recall
The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Alere sent an "URGENT MEDICAL DEVICE RECALL UPDATE" letter dated March 6, 2013 to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers with any questions about the recall notification, are instructed to contact Alere San Diego 9975 Summers Ridge Rd, San Diego, CA 92121; (877) 308-8289; Fax: (858) 805-8457. Customers are instructed to complete the customer response form even if they do not have any involved product.
Quantity in Commerce 38,571 kits
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, South Africa, Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, Philippines, El Salvador, Indonesia, and Trinidad.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CKD and Original Applicant = CHOLESTECH CORP.
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