CLASS II ONGOING Device recall · Reported 21 Aug 2024 · FDA Enforcement Report
Vitros Immunodiagnostic Vitros Folate Reagent Pack 1/2 recalled
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Vitros Folate Reagent Pack 1/2, distributed nationwide in the US. The recall was initiated on 3 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2580-2024
- FDA event ID
- 95020
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jul 2024
- FDA classified
- 12 Aug 2024
- Reported
- 21 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Jul 2024 | Recall initiated by company | |
| 12 Aug 2024 | Classified by FDA | +40 days |
| 21 Aug 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Where it was distributed
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, Sweden, United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Where was it sold?
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, Sweden, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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