Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM
FDA device recall Z-1732-2009 · posted 2009-08-21 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
- Action taken
- An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases. If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at JACTLR@itcmed.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JBP
- Quantity affected
- 173 boxes of 45 cuvettes
- Distribution
- Nationwide.
- Date initiated
- 2009-05-05
- Date posted
- 2009-08-21
- Date terminated
- 2009-09-30
- 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 |