Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation
FDA device recall Z-0837-2013 · posted 2013-02-19 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
- Action taken
- ITC sent an 'Urgent Medical Device Recall' letter/Health Professional Account Tracking Form dated October 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the form whether or not they have remaining inventory of these lots and return the form promptly. All unused returned product will be replaced. Any questions can be directed to ITC Technical Support at 800-631-5945 Extension 4707 or e-mail ProTime@itcmed.com. For questions regarding this recall call 800-631-5945, ext. 4707.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, an
- Date initiated
- 2012-09-28
- Date posted
- 2013-02-19
- Date terminated
- 2014-01-09
- Location
- Edison, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (K010599) | International Technidyne Corp. | 2001-07-02 |