Lower riskMedical device recall · FDA · Published October 11, 2024
Ortho-Clinical VITROS CRP Slides May Give False Low Results for High CRP Samples
Ortho-Clinical recalls VITROS CRP Slides that may show falsely low results for high CRP samples, risking inaccurate health assessments. Affected units have specific model numbers and expiration dates.
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
“Ortho-Clinical VITROS CRP Slides May Give False Low Results for High CRP Samples.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53723-ortho-clinical-vitros-crp-slides-may-give-false-low-results. Based on FDA recall #Z-0535-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2025%22&limit=1).
The FDA announced on Oct. 11, 2024, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because they may generate negatively biased results for samples with high C-reactive protein concentrations. The agency issued recall number Z-0535-2025.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Chemistry Products CRP Slides
Model/Catalog Number: 1926740
UPC/GTIN: 10758750000296
Coating/Lot: 1221 (expiration 10/01/2024)
Coating/Lot: 1222 (expiration 01/01/2025)
The hazard
According to the FDA, the VITROS Chemistry Products CRP Slides may generate negatively biased results when testing samples with high concentrations of C-reactive protein. Specifically, the slides show less than the upper AMI of 90 mg/L for samples in the 70-90 mg/L range while those having higher than 90 mg/L are affected. Users have no way to know if the sample has to be diluted to measure again.
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 Atellica CH RCRP Test (2026-08-17) and Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18).
How to tell if you have this one
Check for model numbers 1926740 with expiration dates 10/01/2024 or 01/01/2025. These slides are used for CRP testing in blood samples.
Brand
Ortho-Clinical
Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Slide Expiration
Verify expiration dates on the slide packaging: 10/01/2024 for coating 1221 or 01/01/2025 for coating 1222.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Florida, Idaho, Illinois, Kansas, Minnesota, Montana, New York, Pennsylvania, Utah.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0535-2025 (October 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0535-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.