IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing
FDA device recall Z-2954-2011 · posted 2011-08-05 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 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,
- Date initiated
- 2011-05-10
- Date posted
- 2011-08-05
- Date terminated
- 2012-11-02
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (K974799) | International Technidyne Corp. | 1998-07-07 |
| MICROCOAGULATION PROTHROMBIN TIME TEST (K940432) | International Technidyne Corp. | 1994-05-18 |