Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

FDA Recall Z-2954-2011 · Posted 2011-08-05

Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeJPA
Date Initiated2011-05-10
Date Terminated2012-11-02
Product Quantity265 boxes total

Reason for Recall

Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments.

Firm Action

International Technidyne Corp. (ITC) sent "Urgent Medical Device Recall" letters dated May 10, May 25 and June 09, 2011 to all affected customers. The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement. For questions, please contact ITC Technical Support at (800) 631-5945.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974799HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATUREInternational Technidyne Corp. · 1998-07-07K940432MICROCOAGULATION PROTHROMBIN TIME TESTInternational Technidyne Corp. · 1994-05-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑