Lower risk Medical device recall · FDA · Published December 16, 2019

Ortho Clinical Diagnostics VITROS Calibrator Kit 2 Recall: Risk of Inaccurate Urine Sodium

Ortho Clinical Diagnostics recalls VITROS Chemistry Calibrator Kit 2 for VITROS 250/350/5,1 FS/4600/XT 3400 systems. This kit may cause inaccurate sodium results in urine tests. Affected lots include 277 (Dec 2019), 288 (May 2020), 298 (Nov 2020), and 219 (Jul 2021).

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

🇺🇸 FDA recall #Z-1226-2020Medical device Ortho Clinical Diagnostics ›

Lower-risk recall

Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

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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 Chemistry Calibrator Kit 2 for certain laboratory systems. This kit may cause inaccurate sodium results in urine tests if used with specific lots. Affected units could lead to incorrect test results if not replaced. Read more at govinfonow.com/recall/66316-ortho-clinical-diagnostics-vitros-calibrator-kit-2-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/66316-ortho-clinical-diagnostics-vitros-calibrator-kit-2-recall-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1226-2020

Cite this page

“Ortho Clinical Diagnostics VITROS Calibrator Kit 2 Recall: Risk of Inaccurate Urine Sodium.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66316-ortho-clinical-diagnostics-vitros-calibrator-kit-2-recall-risk-of. Based on FDA recall #Z-1226-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1226-2020%22&limit=1).

The FDA announced on 2019-12-16 that Ortho Clinical Diagnostics Inc is recalling VITROS Chemistry Products Calibrator Kit 2 due to a potential for negatively biased sodium urine results. The agency issued recall number Z-1226-2020 for the Class II device.

How to tell if you have it

Brand: Ortho Clinical Diagnostics
Product: VITROS Chemistry Products Calibrator Kit 2 - IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Product Code: 1662659
Lot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021
UDI: 10758750009503

The hazard

According to the FDA, the recalled lots of VITROS Chemistry Products Calibrator Kit 2 may produce negatively biased sodium urine results. The recall covers 39,709 units distributed nationwide and in foreign countries including Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, the United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls include Ortho-Clinical 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).

How to tell if you have this one

Check the lot number on the calibrator kit: 277 (expired Dec 2019), 288 (expired May 2020), 298 (expired Nov 2020), or 219 (expired Jul 2021). The product code is 1662659.

Brand
Ortho Clinical Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for the lot number on the calibrator kit: 277, 288, 298, or 219.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands” 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 terminated this recall 11 months after the firm started it.

Dec 16, 2019Firm started the recall
Feb 13, 2020FDA classified it Class II
Feb 19, 2020Published in FDA’s Enforcement Report
Nov 12, 2020FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/66316-ortho-clinical-diagnostics-vitros-calibrator-kit-2-recall-risk-of">Ortho Clinical Diagnostics VITROS Calibrator Kit 2 Recall: Risk of Inaccurate Urine Sodium (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-1226-2020 (December 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1226-2020 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.