AVOXimeter 1000, AVOXimeter 4000 recallZ-2218-2011 · International Technidyne Corp. · initiated Mar 23, 2011
Terminated All recalls posted in May 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from International Technidyne Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
FDA root cause category: Device Design
What the company is doing
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 ([email protected]) 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.
Recall details
- Recall number
- Z-2218-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 23, 2011
- Posted by the FDA
- May 19, 2011
- Recalling firm
- International Technidyne Corp.
- Quantity
- 17
- Product code
- DQA
- FDA submissions
- K951485
- Distribution
- Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
Product description
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
Code information (models, lots, serial numbers)
AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT AVOXimeter 4000: K951485 AVOX4000, AVOX4000D
Other devices under the same FDA submission
1 device cleared under K951485 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Avoximeter Whole Blood CO-Oximeter AVOX4000Accriva Diagnostics Holdings, Inc. · Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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