Recall Z-2954-2011 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
International Technidyne Corp.
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.
| Date | Aug 5, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 265 boxes total |
| Distribution | 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, Q |
| FDA record | Open on fda.gov |