Ortho-Clinical Diagnostics
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
| Date | Feb 21, 2003 (initiated Dec 18, 2002) |
| Status | Terminated |
| Reason | Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II. |
| Root cause | Other |
| Action | Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product. |
| Quantity | 1,338 cartons |
| Distribution | Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013899 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS Ortho-Clinical Diagnostics, Jan 24, 2002 |