VITROS Folate Reagent Pack Recalled for Delayed Test Results
Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II medical device recall involves a reagent malfunction that causes delayed test results. No illnesses, injuries, or hospitalizations are reported, and the source text does not characterize this as a risk-of-harm situation. The defect is functional rather than a direct safety hazard.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2, a diagnostic reagent used in clinical laboratories for folate testing. The recall affects 18,467 units distributed worldwide.
When folate stabilizer reagent is added during the pre-treatment process, fibrinogen in patient plasma samples precipitates out of solution. This causes TM5-4MB condition codes and delays test results.
The affected lots (3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480) have been distributed to clinical laboratories in the United States and in over 20 countries, including Australia, Belgium, Brazil, Canada, Chile, France, Germany, Japan, Mexico, Netherlands, and the United Kingdom.
This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 18,467
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Model No 1513266
- UDI/GTIN# 110758750009237
- Lots within expiry: 3380
- 3390
- 3400
- 3410
- 3422
- 3430
- 3440
- 3450
- 3461
- 3471
- 3480.
Distribution
Distributed nationwide across the United States.
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