medical Class II Updated 2024-02-14

Fujifilm Irvine Scientific, Inc. recalls Sperm separation media are used to separate motile sperm fro

Recalled Product

Sperm separation media are used to separate motile sperm from other constituents of semen.


Hazard / Issue

The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).

Issued by

FDA

Affected States: OK, CA, DC, NC, NV, TX, MI, IN, NY, UT, WI, MN, PA, WV, NJ, IL, LA, WA, OR, FL, IA, AR
Lot/Code Info: UDI-DI: 00857515006009, Lot 0000020693
View official government recall

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