Class 2 Device Recall Alere Cholestech LDX ALT AST Test Cassette

• Date Initiated by Firm: March 06, 2013
• Date Posted: April 17, 2013
• Recall Status: Terminated on August 13, 2013
• Recall Number: Z-1139-2013
• Recall Event ID: 64671
• 510(K)Number: 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 CA 92121-2997
• For Additional Information Contact: 858-805-2000 Ext. 3015
• 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: Other
• 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 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 = CKD