Z-2218-2011

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

Name: Z-2218-2011 AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures...
Creator: International Technidyne Corp.
Published: 2011-03-23
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2011-03-23 / Terminated / root cause: design

FDA source

International Technidyne Corp. began a recall of AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration... on 2011-03-23. The reason FDA records is "An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2218-2011
Status: Terminated
Initiated: 2011-03-23
Posted: 2011-05-19
Terminated: 2012-10-25
Recalling firm: Accriva Diagnostics, Inc.
Product: 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.
Product code: DQA Oximeter
Reason for recall: An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 17
Distribution: Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
Product codes and lots: AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT AVOXimeter 4000: K951485 AVOX4000, AVOX4000D

Product code DQA

K951485Class IAvoximeter 4000A-Vox Systems, Inc. / cleared 1995-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)