Official recall record
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-07-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Ortho-Clinical Diagnostics, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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