Sperm separation media kits recalled for incorrect component lot
Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.
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 is an FDA Class II recall with no reported illnesses or injuries. The issue is a manufacturing quality control failure where an incorrect lower layer component may have been packaged. While this could affect product performance, no harm has been documented, making this a moderate-severity recall.
Plain-English summary
Fujifilm Irvine Scientific, Inc. is recalling sperm separation media kits (Lot 0000020693) used to separate motile sperm from other constituents of semen. The kits should contain lower layer component Lot 0000020686 (shelf life: December 31, 2024) but may contain lower layer component Lot 9925811106 (shelf life: November 30, 2023).
The incorrect component does not match the product's certificate of analysis. This mismatch could compromise the kit's performance for sperm separation.
246 units were distributed in the United States (Oklahoma, California, District of Columbia, North Carolina, Nevada, Texas, Michigan, Indiana, New York, Utah, Wisconsin, Minnesota, Pennsylvania, West Virginia, New Jersey, Illinois, Louisiana, Washington, Oregon, Florida, and Iowa) and internationally (United Kingdom, Netherlands, Argentina, and Malaysia).
If you have one of the affected kits, contact Fujifilm Irvine Scientific, Inc. for instructions on how to proceed. Do not use kits that are confirmed to contain lot number 9925811106.
The recalled product
- Product
- Sperm separation media are used to separate motile sperm from other constituents of semen.
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
- Affected units
- 246
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 (2)
- UDI-DI: 00857515006009
- Lot 0000020693
Distribution
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