Fujifilm Irvine Scientific, Inc.: Sperm separation media are used to separate motile sperm from other constituents of semen.

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: US: OK, CA, DC, NC, NV, TX, MI, IN, NY, UT, WI, MN, PA, WV, NJ, IL, LA, WA, OR, FL, IA. OUS: GB, NL, AR, MY Quantity: 246 Lot/code info: UDI-DI: 00857515006009, Lot 0000020693

UPC codes

00857515006009

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.