Recall Z-0913-05 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
| Date | Jun 21, 2005 (initiated Mar 15, 2005) |
| Status | Terminated |
| Reason | Potential for positively biased results in QC and patient samples. |
| Root cause | Other |
| Action | Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack. |
| Quantity | Domestic - 1359; International - 840 |
| Distribution | Nationwide distribution. Product shipped worldwide via J&J foreign affiliates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc., Dec 18, 1996 |