CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clin
FDA device recall Z-0557-03 · posted 2003-02-21 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
- Action taken
- Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 1,338 cartons
- Distribution
- Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
- Date initiated
- 2002-12-18
- Date posted
- 2003-02-21
- Date terminated
- 2003-04-14
- 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 |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS (K013899) | Ortho-Clinical Diagnostics | 2002-01-24 |