Lower risk Medical device recall · FDA · Published July 12, 2018

Ortho Clinical Diagnostics VITROS Folate Reagent Pack Recall: Biotin Supplements May Cause

Ortho Clinical Diagnostics recalls VITROS Folate Reagent Packs due to potential biased test results when patients take biotin supplements below the indicated concentration in the instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0058-2019Medical device Ortho Clinical Diagnostics ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOrtho Clinical Diagnostics Inc1001 US Highway 202 · Raritan, NJ 08869-1424

✎ GovInfoNow plain-language explainer

Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because patients taking biotin supplements might get inaccurate test results. This could affect blood tests for certain conditions if the biotin levels are lower than what the instructions specify. Read more at govinfonow.com/recall/70612-ortho-clinical-diagnostics-vitros-folate-reagent-pack-recall-biotin-supplements.

Source Summary by GovInfoNow · govinfonow.com/recall/70612-ortho-clinical-diagnostics-vitros-folate-reagent-pack-recall-biotin-supplements · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0058-2019

Cite this page

“Ortho Clinical Diagnostics VITROS Folate Reagent Pack Recall: Biotin Supplements May Cause.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70612-ortho-clinical-diagnostics-vitros-folate-reagent-pack-recall-biotin-supplements. Based on FDA recall #Z-0058-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2019%22&limit=1).

The FDA announced on July 12, 2018, that Ortho Clinical Diagnostics Inc. is recalling VITROS Immunodiagnostic Products - Folate Reagent Pack due to potential biased results for patients taking biotin supplements. The recall affects 7,880 units distributed worldwide.

How to tell if you have it

Brand: Ortho Clinical Diagnostics
Product: VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Model numbers: 2470, 2480, 2490, 2501, 2510, 2521
Quantity: 7,880 units

The hazard

The firm determined that biased results may occur for specific VITROS Immunodiagnostic Products at biotin concentrations lower than indicated in the current Instructions For Use. Patients taking biotin supplements could potentially have biased sample results for affected assays.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Recent brand recalls include calibration failures affecting VITROS Chemistry Products LAC Slides and VITROS Ca Slides in July 2025, and inaccurate test results from VITROS OP Reagent Gen 15 in June 2025. Other recent recalls of similar products include Vivoo Test Strips Recall (Nov. 22, 2025), Vivoo Protein Test Recall (Nov. 22, 2025), and Vivoo pH Test Recall (Nov. 22, 2025).

How to tell if you have this one

Check for the VITROS Folate Reagent Pack with the model number 10758750009237. This product was sold in specific batches and models listed in the recall notice.

Brand
Ortho Clinical Diagnostics
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.

Recall number	Product, codes & lots	Quantity
Z-0058-2019	VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266; 2470 2480 2490 2501 2510 2521	7880
Z-0059-2019	VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922; 2470 2480 2490 2500 2510 2520 2530	1955
Z-0060-2019	VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793; 2330 2340 2350 2360 2370 2380	1790
Z-0061-2019	VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997; 5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690	68230

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the model number 10758750009237 on the VITROS Folate Reagent Pack.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 12, 2018Firm started the recall
Oct 3, 2018FDA classified it Class II
Oct 10, 2018Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this product?

No, but you should check if you have the recalled model and consider discussing biotin use with your healthcare provider if you take supplements.

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Link to this recall

<a href="https://govinfonow.com/recall/70612-ortho-clinical-diagnostics-vitros-folate-reagent-pack-recall-biotin-supplements">Ortho Clinical Diagnostics VITROS Folate Reagent Pack Recall: Biotin Supplements May Cause (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0058-2019 (July 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0058-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.