Class 2 Device Recall Teledyne Analytical Instruments

• Date Initiated by Firm: October 27, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on February 20, 2004
• Recall Number: Z-0145-04
• Recall Event ID: 27593
• Product Classification: Analyzer, Gas, Oxygen, Gaseous-Phase - Product Code CCL
• Product: Portable Oxygen Analyzer
• Code Information: Model AX300, Model MX300
• Recalling Firm/ Manufacturer: Teledyne Analytical Instruments; 16830 Chestnut St; Rowland Heights CA 91748-1017
• For Additional Information Contact: Ray Khajavi; 949-934-1502
• Manufacturer Reason for Recall: Potential failure to display the battery low light to the end-user.
• FDA Determined Cause: Other
• Action: All affected customers will be notified by letter on 10/27/2003. All units returned will be reworked and 100% retested prior to shipment.
• Quantity in Commerce: 170
• Distribution: FL, CA, UT, AZ and MO. New Zealand, Australia, Canada and the United Kingdom
• 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.