AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fracti

FDA device recall Z-2218-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

International Technidyne Corp.

Reason for recall

An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.

Action taken

International Technidyne Corp. sent a letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to: ITC Technical Support 20 Corporate Place South Piscataway, New Jersey 08854 For any questions call the Distributor or ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International), ext 4707.

Root cause

Device Design

Status

Terminated

Product code

DQA

Quantity affected

17

Distribution

Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand

Date initiated

2011-03-23

Date posted

2011-05-19

Date terminated

2012-10-25

Location

Edison, NJ

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