Recall Z-2302-2016 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITRO
| Date | Jun 2, 2016 |
| Status | Terminated |
| Reason | Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack. |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2016-112) dated June 2, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product to inform them that sample results generated using VITROS Total T4 Reagent Packs that are opened for more than 4 weeks may produce a negative bias and advised them to only use the Total T4 Reagent Pack up to 4 weeks after the pack has been opened. Foreign affiliates were info |
| Quantity | US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda |
| Distribution | Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda |
| 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 |