Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Sc
FDA device recall Z-1031-03 · posted 2003-07-19 · Terminated
Recall details
- Recalling firm
- Zeus Scientific Inc
- Reason for recall
- Calibrator C not meeting its optical density specification.
- Action taken
- Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHR
- Quantity affected
- 505
- Distribution
- The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
- Date initiated
- 2001-11-09
- Date posted
- 2003-07-19
- Date terminated
- 2006-10-03
- 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 |
|---|---|---|
| RF IGM ELISA TEST SYSTEM (K961277) | Zeus Scientific, Inc. | 1996-05-08 |