Lower risk Medical device recall · FDA · Published February 18, 2021

Ortho-Clinical VITROS TIBC Calibrator Kit Recall: Potential TIBC Results Shift

Ortho-Clinical recalls VITROS TIBC Calibrator Kits and Fe Slides with potential 80 ug/dL lower TIBC results starting from GEN 26 slides. Affected kits and slides may cause inaccurate blood test results.

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

🇺🇸 FDA recall #Z-1295-2021Medical device Ortho-Clinical ›

Lower-risk recall

Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).

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 TIBC Calibrator Kits and Fe Slides that could cause blood test results to be 80 ug/dL lower than expected. This affects patients using these products for iron-related blood tests. Read more at govinfonow.com/recall/63258-ortho-clinical-vitros-tibc-calibrator-kit-recall-potential-tibc-results.

Source Summary by GovInfoNow · govinfonow.com/recall/63258-ortho-clinical-vitros-tibc-calibrator-kit-recall-potential-tibc-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1295-2021

Cite this page

“Ortho-Clinical VITROS TIBC Calibrator Kit Recall: Potential TIBC Results Shift.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63258-ortho-clinical-vitros-tibc-calibrator-kit-recall-potential-tibc-results. Based on FDA recall #Z-1295-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2021%22&limit=1).

The FDA announced on Feb. 18, 2021, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 due to potential total iron-binding capacity (TIBC) results shifting approximately 80 ug/dL lower than expected.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only)
Product Code: 1204668
Impacted Products A: VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots
Impacted Products B: VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289)
Product No: 1515808 300 slides (UDI 10758750009244)
Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots
Lot Numbers: 0449 (exp. 28-Aug-2021), 0459 (exp. 10-Feb-2022), 0460 (exp. 01-Oct-2022)
UDI: (10758750008537)

The hazard

The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), and the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).

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 Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16), Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), and Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18).

How to tell if you have this one

Check for the product codes: VITROS TIBC Kit (Product No: 7541) or Fe Slides (Product Nos: 1924547, 1515808, 6802198). The affected slides are all current and new lots with specific lot numbers listed in the recall notice.

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your VITROS TIBC Calibrator Kit or Fe Slides match the product codes and lot numbers 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 distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore…” 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 20 months after the firm started it.

Feb 18, 2021Firm started the recall
Mar 23, 2021FDA classified it Class II
Mar 31, 2021Published in FDA’s Enforcement Report
Oct 18, 2022FDA terminated the recall

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

What should I do if I have the recalled products?

Check the product codes and lot numbers listed in the recall notice to determine if your items are affected. The recall does not require immediate action but should be addressed to ensure accurate test results.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63258-ortho-clinical-vitros-tibc-calibrator-kit-recall-potential-tibc-results">Ortho-Clinical VITROS TIBC Calibrator Kit Recall: Potential TIBC Results Shift (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-1295-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1295-2021 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.