Recall Z-2953-2011

International Technidyne Corp. · initiated May 10, 2011

Terminated

Product

Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

Codes / lots: Catalogue/Code J201 Lot Number: FOJPT059, GOJPT067, GOJPT068, GOJPT069, GOJPT070, GOJPT072, GOJPT073, GOJPT074, GOJPT075, HOJPT076, HOJPT077, HOJPT078, HOJPT079, HOJPT080, HOJPT081, HOJPT082, HOJPT083, JOJPT084, JOJPT085, JOJPT086, JOJPT087, JOJPT088, JOJPT090, KOJPT091, KOJPT092, KOJPT093, MOJPT094, MOJPT095, MOJPT096, MOJPT097, MOJPT098, MOJPT099, A1JPT001, A1JPT002 A1JPT003 A1JPT005 A1JPT007 A1JPT008, A1JPT009, A1JPT010, A1JPT011, A1JPT012, A1JPT013, A1JPT014, A1JPT015, A1JPT016, A1JPT017, A1JPT018, A1JPT019, A1JPT021, A1JPT023, A1JPT024, A1JPT025, B1JPT032, B1JPT033, C1JPT035, C1JPT038, C1JPT041, and C1JPT045.

Reason for recall

Certain lots of Hemochron Jr. PT Cuvettes (J201) 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-2953-2011
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
6,218 boxes in US ; 4713 boxes outside US
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2954-2011 IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation…Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than… 05/10/2011Terminated