Recall Z-2302-2016— ORTHO-CLINICAL DIAGNOSTICS

Name: FDA recall Z-2302-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-02

Class II · Terminated

Class II FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2016-06-02, terminated 2018-06-08. It names one FDA 510(k) clearance: K964721. 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: 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..

Recalling firm: ORTHO-CLINICAL DIAGNOSTICS
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Terminated: 2018-06-08
Firm location: Bridgend, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K964721 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc.·cleared 1996-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.