Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma.
FDA device recall Z-0919-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Slides may exhibit random, elevated imprecision of results.
- Action taken
- Notification via letter dated 3/26/03 with instructions to discard product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEK
- Quantity affected
- 29,273 (domestic); 4,967 (international)
- Distribution
- Nationwide and Worldwide.
- Date initiated
- 2003-03-26
- Date posted
- 2003-06-05
- Date terminated
- 2004-11-16
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) (K812028) | Eastman Kodak Company | 1981-08-03 |