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U.S. Department of Health and Human Services

Class 2 Device Recall ACE ALT Reagent Kits

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  Class 2 Device Recall ACE ALT Reagent Kits see related information
Date Initiated by Firm March 05, 2014
Date Posted April 30, 2014
Recall Status1 Terminated 3 on August 13, 2015
Recall Number Z-1529-2014
Recall Event ID 67897
510(K)Number K131351  
Product Classification Nadh oxidation/nad reduction, alt/sgpt - Product Code CKA
Product Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent.

Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
Code Information ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)
Recalling Firm/
Alfa Wassermann, Inc.
4 Henderson Dr
West Caldwell NJ 07006-6608
For Additional Information Contact Customer Solution Center
Manufacturer Reason
for Recall
Extremely low absorbance readings.
FDA Determined
Cause 2
Process control
Action Alfa Wassermann Diagnostic Technologies, LLC issued an "Important: Advisory Notice/"Product Response Form" dated March 5, 2014 and sent on March 6, 2014 to their customers for ACE¿ ALT Reagent Product reorder number SA1046 Lot F3604. They issued a follow-up "Important: Advisory Notice/"Product Response Form" dated March 21, 2014 and sent on March 26, 2014 to their customers for ACE¿ AST Reagent Product reorder numbers SA1047, Lot F3609, and RX1047, Lot F3610. The notification identified the product(s), problem, and actions to be taken by the customers. Customers were instructed to destroy any affected product and complete and submit the enclosed Product Response Form. For questions or concerns, contact the Alfa Wassermann Diagnostic Technologies, LLC Customer Solution Center, Toll Free: (866) 419-ALFA (2532).
Quantity in Commerce 731 Kits
Distribution US Nationwide Distribution
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 = CKA and Original Applicant = ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC