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U.S. Department of Health and Human Services

Class 3 Device Recall AxSYM System Tubing Decontamination Solution

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 Class 3 Recall
AxSYM System Tubing Decontamination Solution
see related information
Date Posted September 30, 2009
Recall Status1 Terminated on July 08, 2010
Recall Number Z-2317-2009
Recall Event ID 51258
Premarket Notification
510(K) Number
K974651 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.
Code Information List 7B05-09, Lot Number: 211974, expiration date 9/30/09.
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall
Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.
Quantity in Commerce 1,965 kits
Distribution Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.
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 = JJE and Original Applicant = ABBOTT LABORATORIES
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