Food, drugs, devices › ORTHO-CLINICAL DIAGNOSTICS
Device recall: VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147,
FDA enforcement event 74366 is a device recall by ORTHO-CLINICAL DIAGNOSTICS of Bridgend, initiated 2 Jun 2016 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 8 Jun 2018. Initiation: voluntary: firm initiated. ORTHO-CLINICAL DIAGNOSTICS has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ORTHO-CLINICAL DIAGNOSTICS, Bridgend, United Kingdom.
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."
Distribution
"Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2302-2016 | 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… | US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda | Class II | Terminated | 10 Aug 2016 |
Context
Other enforcement events for ORTHO-CLINICAL DIAGNOSTICS
All 105 events for ORTHO-CLINICAL DIAGNOSTICS
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.