VITROS Immunodiagnostic Products Total T4 Reagent Pack — Class II medical device recall Z-2302-2016
Terminated recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2016-08-10, distributed nationwide. Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total
| Recall number | Z-2302-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, United Kingdom |
| Recall initiated | 2016-06-02 |
| Classified | 2016-07-29 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2018-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| UPC / GTIN / UDI-DI | 10758750005147 |
| Lot numbers | 1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998 |
Product
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 VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2302-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.