Recall Z-1460-05 ยท LCD Enzyme Immunoassay, Gentamicin
Ortho-Clinical Diagnostics
VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
| Date | Sep 1, 2005 (initiated Jul 19, 2005) |
| Status | Terminated |
| Reason | Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours. |
| Root cause | Other |
| Action | Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots. |
| Quantity | 443 boxes |
| Distribution | The product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042479 | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE Ortho-Clinical Diagnostics, Inc., Jan 6, 2005 |