IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
FDA device recall Z-1129-03 · posted 2003-08-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
- Action taken
- Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 423 kits
- Distribution
- California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Ge
- Date initiated
- 2003-07-22
- Date posted
- 2003-08-13
- Date terminated
- 2003-09-16
- 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 RUBELLA IGM ANTIBODY ASSAY (K931059) | Abbott Laboratories | 1994-12-19 |