Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnosti
FDA device recall Z-1381-05 · posted 2005-08-23 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
- Action taken
- Recall letter was sent out on 4/27/2005 via First Class Mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 924 boxes x 45 cuvettes per box
- Distribution
- Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Produ
- Date initiated
- 2005-04-27
- Date posted
- 2005-08-23
- Date terminated
- 2005-08-25
- 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. MICROCOAGULATION LOW RANGE ACT (K960749) | International Technidyne Corp. | 1996-08-12 |