Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
FDA device recall Z-1095-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Zeus Scientific Inc
- Reason for recall
- The Calibrator included within the kit may be losing reactivity.
- Action taken
- All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFZ
- Quantity affected
- 270 kits
- Distribution
- The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.
- Date initiated
- 2003-06-12
- Date posted
- 2003-08-12
- Date terminated
- 2006-02-22
- 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 |
|---|---|---|
| CMV ELISA TEST SYSTEM (K891081) | Zeus Scientific, Inc. | 1989-06-02 |