Lower risk Medical device recall · FDA · Published October 13, 2022

Ortho-Clinical VITROS Calibrator Kit 9 (GEN 22) May Cause Delayed Test Results

Ortho-Clinical recalls VITROS Chemistry Calibrator Kit 9 (GEN 22) due to calibration errors causing delayed test results. Affected units include specific slide generations and lots.

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

🇺🇸 FDA recall #Z-0220-2023Medical device Ortho-Clinical ›

Lower-risk recall

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.1001 Us Highway 202 · Raritan, NJ 08869-1424

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS Chemistry Calibrator Kit 9 (GEN 22) because faulty calibration math prevents proper testing, leading to delayed results. This affects lab equipment used for in vitro diagnostics. Read more at govinfonow.com/recall/59920-ortho-clinical-vitros-calibrator-kit-9-gen-22-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/59920-ortho-clinical-vitros-calibrator-kit-9-gen-22-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0220-2023

Cite this page

“Ortho-Clinical VITROS Calibrator Kit 9 (GEN 22) May Cause Delayed Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59920-ortho-clinical-vitros-calibrator-kit-9-gen-22-may-cause. Based on FDA recall #Z-0220-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0220-2023%22&limit=1).

The FDA announced on 2022-10-13 that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides because erroneous calibration mathematics prevents successful system calibration and leads to delayed results.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides
Product Code: 8568040
Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991 01-MAR-2023
Slide Generation: GEN 22, All lots
Calibration Diskette Data Release Versions (DRVs): 6194 through 6200
Units affected: 17,396

The hazard

According to the FDA, calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9. This error prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent brand recalls include the 2025-07-29 VITROS LAC Slides Recall for calibration failures and the 2025-07-09 VITROS Ca Slides Recall for similar calibration issues. Other recent recalls of similar products include Medline Convenience Kits: Calibration Issues May Impact Sterility Assurance (2026-01-07) and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07).

How to tell if you have this one

Check for VITROS Chemistry Calibrator Kit 9 (GEN 22) with slide generation 22. Product lots include 0911 (May 2023), 0921 (Oct 2023), 0942 (Jun 2024), 0980 (Oct 2022), and 0991 (Mar 2023).

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if your VITROS Calibrator Kit 9 is labeled GEN 22 with the specific lots listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal…” 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 34 days after the firm started it.

Oct 13, 2022Firm started the recall
Nov 10, 2022FDA classified it Class II
Nov 16, 2022Published 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, the recall does not require immediate discontinuation. Affected units should be checked for the specific lots and generation.

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Link to this recall

<a href="https://govinfonow.com/recall/59920-ortho-clinical-vitros-calibrator-kit-9-gen-22-may-cause">Ortho-Clinical VITROS Calibrator Kit 9 (GEN 22) May Cause Delayed 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-0220-2023 (October 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0220-2023 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.