Recall Z-0173-06 ยท LEH Radioimmunoassay, Vancomycin
Ortho-Clinical Diagnostics
VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
| Date | Nov 18, 2005 (initiated Oct 12, 2005) |
| Status | Terminated |
| Reason | Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days. |
| Root cause | Other |
| Action | Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005. |
| Quantity | 784 boxes x 6 packs x 50 tests |
| Distribution | Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc., Feb 7, 2005 |