Food, drugs, devices › Ortho Clinical Diagnostics Inc
Device recall: VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Ortho Clinical Diagnostics Inc (Raritan, NJ) initiated this device recall on 12 Jul 2018; FDA lists 4 product records under event 80717, classified Class II.
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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Ortho Clinical Diagnostics Inc has 54 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 Inc, Raritan, NJ.
Reason for recall
"The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU."
Distribution
"Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0058-2019 | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 | 7880 | Class II | Ongoing | 10 Oct 2018 |
| Z-0059-2019 | VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 | 1955 | Class II | Ongoing | 10 Oct 2018 |
| Z-0060-2019 | VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793 | 1790 | Class II | Ongoing | 10 Oct 2018 |
| Z-0061-2019 | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 | 68230 | Class II | Ongoing | 10 Oct 2018 |
Context
Other enforcement events for Ortho Clinical Diagnostics Inc
All 54 events for Ortho Clinical Diagnostics Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU."
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 distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.