Recall Z-0866-05 ยท LEG Enzyme Immunoassay, Valproic Acid
Ortho-Clinical Diagnostics
VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
| Date | Jun 4, 2005 (initiated Apr 18, 2005) |
| Status | Terminated |
| Reason | Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days. |
| Root cause | Other |
| Action | Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available. |
| Quantity | 139 boxes |
| Distribution | 37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042476 | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS Ortho-Clinical Diagnostics, Inc., Dec 1, 2004 |