FDA Medical Device Recalls (openFDA)
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 VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
- Recall number
- Z-2302-2016
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- 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.
- Status
- Terminated
- Initiated
- 2016-06-02
- Posted
- not on file
- Terminated
- 2018-06-08
- 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 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
- 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
- Lot, serial or model codes
- Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998
- 510(k) numbers
- K964721
- PMA numbers
- not on file
- Product code
- KLI
- Firm FEI
- 3007111389
- Firm city
- Bridgend
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28