International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog
FDA device recall Z-2200-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
- Action taken
- ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GGN
- Quantity affected
- 122 boxes in US, 1 out of US.
- Distribution
- Nationwide and one customer in Belgium.
- Date initiated
- 2010-06-25
- Date posted
- 2010-08-10
- 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 |