Lower risk Medical device recall · FDA · Published November 17, 2022

Ortho-Clinical VITROS iPTH Reagent Pack Recall: Negative Bias in Test Results

Ortho-Clinical recalls VITROS iPTH reagent packs with negative bias in test results. Affected lots may cause inaccurate parathyroid hormone measurements. Contact for remedy details.

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

🇺🇸 FDA recall #Z-0878-2023Medical device Ortho-Clinical ›

Lower-risk recall

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS iPTH reagent packs that may produce test results 12% lower than actual patient levels. This could lead to incorrect diagnoses if used in medical testing. Read more at govinfonow.com/recall/59362-ortho-clinical-vitros-ipth-reagent-pack-recall-negative-bias-in.

Source Summary by GovInfoNow · govinfonow.com/recall/59362-ortho-clinical-vitros-ipth-reagent-pack-recall-negative-bias-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0878-2023

Cite this page

“Ortho-Clinical VITROS iPTH Reagent Pack Recall: Negative Bias in Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59362-ortho-clinical-vitros-ipth-reagent-pack-recall-negative-bias-in. Based on FDA recall #Z-0878-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2023%22&limit=1).

The FDA announced on November 17, 2022, that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD due to lower than expected patient and Quality Control results. The agency said the reagent packs may produce negatively biased intact parathyroid hormone readings.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD
Catalog Number: 6802892
UDI-DI: 6802892 (10758750006267)
Lot Numbers/Exp Date: 1610 24-Apr-2023; 1621 24-Apr-2023; 1630 08-May-2023; 1640 08-May-2023; 1645 08-May-2023; 1650 29-May-2023; 1670 06-Jun-2023
Quantity: 4,158 units

The hazard

The recall addresses lower than expected intact parathyroid hormone (iPTH) patient and Quality Control results. The FDA said the issue involves negatively biased iPTH results, specifically an average -12% shift in patient sample results.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Ortho-Clinical VITROS LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07), Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), and Vivoo pH Test Recall (2025-11-22).

How to tell if you have this one

Check the lot numbers on the reagent pack: 1610, 1621, 1630, 1640, 1645, 1650, or 1670. These were sold with specific expiration dates starting from April 2023.

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Number
Look for lot numbers 1610, 1621, 1630, 1640, 1645, 1650, or 1670 on the reagent pack.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, 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 55 days after the firm started it.

Nov 17, 2022Firm started the recall
Jan 4, 2023FDA classified it Class II
Jan 11, 2023Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/59362-ortho-clinical-vitros-ipth-reagent-pack-recall-negative-bias-in">Ortho-Clinical VITROS iPTH Reagent Pack Recall: Negative Bias in Test Results (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-0878-2023 (November 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0878-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.