CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in T
FDA device recall Z-0680-03 · 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
- 792 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 |
| AXSYM CA 15-3 (K963926) | Abbott Laboratories | 1997-09-15 |