Vitrolife Recalls SpermMAR IgA Test Kits Due to Sperm Motility Reduction
Vitrolife Inc is recalling 45 kits of SpermMAR IgA test because a new formulation reduces sperm cell motility in certain samples.
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: The recall is classified as FDA Class II, and the hazard involves a functional defect (reduced motility) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Vitrolife Inc is recalling 45 kits of SpermMAR IgA test kits, specifically lots FP14A09, FP14A10, and FP14A11. The recall is due to a new formulation in the bead solution that causes the motility of sperm cells to reduce in certain samples when the solution is added.
The affected products were distributed in the United States to the state of Oregon and internationally to Argentina. The kits are intended for in vitro diagnostic use.
Consumers and healthcare providers should stop using the affected kits and contact Vitrolife Inc for further instructions or a replacement.
The recalled product
- Product
- SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial…
- Manufacturer
- Vitrolife Inc
- Hazard
- Affected units
- 45
Distribution
Distributed in 1 state:
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