Lower riskMedical device recall · FDA · Published May 21, 2024
Ortho-Clinical VITROS Chemistry Diluent Pack 3 May Cause Inaccurate Test Results
Ortho-Clinical recalls VITROS Chemistry Diluent Pack 3 (Lot 01-1645) that may cause inaccurate test results when used with CRP Slides. Affected units include specific model and lot numbers.
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
“Ortho-Clinical VITROS Chemistry Diluent Pack 3 May Cause Inaccurate Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55040-ortho-clinical-vitros-chemistry-diluent-pack-3-may-cause-inaccurate. Based on FDA recall #Z-2266-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2266-2024%22&limit=1).
The FDA announced on May 21, 2024, that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products FS Diluent Pack 3 due to potential biased test results. The agency issued recall number Z-2266-2024 for the voluntary Class II action.
The VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
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 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 Creatinine Flex Reagent Cartridge Recall (2026-03-18), Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07), and HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk (2026-06-08).
How to tell if you have this one
Check for the model number 6801754 and lot number 01-1645 on the diluent pack. The product comes with 3 packs per sales unit and expires on July 5, 2024.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number 6801754 and lot number 01-1645 on the diluent pack.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, 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.
Named in the notice: Florida, Illinois, New York, Pennsylvania.
Recall timeline
FDA published this recall 50 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-2266-2024 (May 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2266-2024 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.