ICON DS hCG, an in-vitro diagnostic. Part number 44025.
FDA device recall Z-0706-03 · posted 2003-04-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
- Action taken
- Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 12,804
- Distribution
- Nationwide and Canada.
- Date initiated
- 2003-02-20
- Date posted
- 2003-04-02
- Date terminated
- 2003-09-25
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACON ONE STEP PREGNANCY TEST STRIP (URINE) (K993203) | ACON Laboratories, Inc. | 1999-12-01 |