Recall Z-2954-2011
International Technidyne Corp. · initiated May 10, 2011
Product
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.
Codes / lots: ID #: 6260030000. Lot Numbers: A1ILJPT001, H0ILJPT005, and K0ILJPT006.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2954-2011
- Initiated
- May 10, 2011
- Posted by FDA
- August 5, 2011
- Terminated
- November 2, 2012
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- 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, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
- Recalling firm
- International Technidyne Corp., Edison, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2953-2011 | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine…Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when… | 05/10/2011Terminated |