Fujifilm Irvine Scientific, Inc. has recalled 246 units of its Sperm Separation Kit because a critical internal component does not match the kit's certificate of analysis. Specifically, the kit's lower layer component was found to be from an incorrect lot with a significantly shorter shelf life than required. Affected kits were distributed across 21 U.S. states and several international locations. Consumers should contact their healthcare provider or the manufacturer for instructions on how to handle affected inventory.
The use of a mismatched or expired component in sperm separation media may lead to suboptimal performance of the medical device during fertility procedures. This could potentially affect the quality of motile sperm separation, which is a critical step in reproductive health treatments.
Manufacturer Notification and Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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