Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM a
FDA device recall Z-1065-03 · posted 2003-07-30 · Terminated
Recall details
- Recalling firm
- Zeus Scientific Inc
- Reason for recall
- The high positive control/low positive standard ratio recovering too low.
- Action taken
- Recall letters sent out via DHL on 2/24/2000
- Root cause
- Other
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 205
- Distribution
- The two lots were shipped to St. Louis, MO. No subrecall was initiated.
- Date initiated
- 2000-02-24
- Date posted
- 2003-07-30
- Date terminated
- 2004-10-25
- Location
- Branchburg, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM (K984180) | Zeus Scientific, Inc. | 1999-07-20 |