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U.S. Department of Health and Human Services

Class 2 Device Recall Architect AUSAB REAGENT Kit

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  Class 2 Device Recall Architect AUSAB REAGENT Kit see related information
Date Initiated by Firm May 14, 2007
Date Posted July 24, 2007
Recall Status1 Terminated 3 on June 10, 2011
Recall Number Z-1096-2007
Recall Event ID 37961
PMA Number P050051 
Product Classification in vitro diagnostic - Product Code LOM
Product ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.
Code Information PRODUCT LIST NUMBER = 1L82-25 Lot numbers = 48453Q100 Exp date 03/23/2008, 46687Q100 Exp date 05/01/2007, 44801Q100 Exp date 02/28/2007, 42577Q100 Exp date 12/05/2006, and 43270Q100 Exp date 01/06/2007
Recalling Firm/
Abbott Diagnostic International, Ltd.
30 Bo Cruce Davila
Barceloneta PR 00617-3009
Manufacturer Reason
for Recall
During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.
FDA Determined
Cause 2
Action All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form > Product Information Letter to be included in new kits to be distributed. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed to: Please follow their laboratory procedures for evaluation of these results Disregard the automated interpretation of results for low-level reactive samples. A customer reply form will accompany the Product Correction letter. Effectiveness Check Depth: 100% of customers receiving the Product Correction letter. The start date of communication was May 14,2007.
Quantity in Commerce 1494
Distribution Nationwide and Puerto Rico
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.
PMA Database PMAs with Product Code = LOM and Original Applicant = ABBOTT LABORATORIES INC