It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
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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 Folate Reagent Pack 1/2 because fibrinogen in patient samples can precipitate when the reagent is added, leading to delayed test results. This affects lab tests and could cause inaccurate health assessments if not corrected. Read more at govinfonow.com/recall/54698-ortho-clinical-vitros-folate-reagent-pack-1-2-delayed-test.
“Ortho-Clinical VITROS Folate Reagent Pack 1/2: Delayed Test Results Due to Fibrinogen.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54698-ortho-clinical-vitros-folate-reagent-pack-1-2-delayed-test. Based on FDA recall #Z-2580-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2024%22&limit=1).
The FDA announced on July 3, 2024, that Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack 1/2 because fibrinogen precipitation can delay test results. The company initiated the voluntary Class II recall affecting 18,467 units distributed worldwide.
According to the FDA, fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent. This causes an increase in "TM5-4MB" condition codes which lead to a delay of results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Recent similar recalls include the Ortho-Clinical LAC Slides Recall (July 29, 2025) and the Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025). Other recent recalls of similar products include the HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (Nov. 18, 2025) and the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check for model number 1513266 on the reagent pack. Affected lots are 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, and 3480.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Number
Identify the lot number on the VITROS Folate Reagent Pack 1/2 to see if it is affected (3380-3480).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, 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 published this recall 49 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-2580-2024 (July 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2580-2024 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.