IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other
FDA device recall Z-0681-03 · posted 2003-03-26 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD
- Reason for recall
- The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
- Action taken
- Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- MOI
- Quantity affected
- 409 packs
- Distribution
- Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
- Date initiated
- 2003-03-04
- Date posted
- 2003-03-26
- Date terminated
- 2004-09-15
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMX CA 15-3 (K964407) | Abbott Laboratories | 1997-11-10 |