directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
FDA device recall Z-1786-2010 · posted 2010-06-11 · Terminated
Recall details
- Recalling firm
- International Technidyne Corporation
- Reason for recall
- Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.
- Action taken
- Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GGN
- Quantity affected
- 94 boxes
- Distribution
- Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.
- Date initiated
- 2010-04-15
- Date posted
- 2010-06-11
- Date terminated
- 2010-09-23
- 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 |
|---|---|---|
| ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II (K944691) | International Technidyne Corp. | 1995-03-15 |