Z-2302-2016Class II

VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No...

Name: Z-2302-2016 VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No...
Creator: Ortho-Clinical Diagnostics
Published: 2016-06-02
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-06-02 / Terminated / root cause: labeling and UDI

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics... on 2016-06-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2302-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Posted: 2016-07-29
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
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.
Root cause tag: labeling and UDI
FDA 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 informed of the issue by e-mail on 6June 2, 2016, and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Global Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 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
Product codes and lots: Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2302-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-07-29

Product code KLI

K964721Class IIVitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators (Gem.c005)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)