| Class 2 Device Recall Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). |  |
Date Initiated by Firm | May 10, 2011 |
Date Posted | August 05, 2011 |
Recall Status1 |
Terminated 3 on November 02, 2012 |
Recall Number | Z-2953-2011 |
Recall Event ID |
58043 |
510(K)Number | K940432 K974799 |
Product Classification |
Microcoagulation Systems; Prothrombin Time (PT) - Product Code JPA
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
International Technidyne Corp. 68 Olsen Ave Edison NJ 08820-2419
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For Additional Information Contact | Ms. Ellie Fox 732-548-5700 |
Manufacturer 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 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JPA
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