FDA-Device2024-02-14Class II
Sperm separation media are used to separate motile sperm from other constituents of semen.
Fujifilm Irvine Scientific, Inc.
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).
Sold states
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
Affected count
246
Manufactured in
2511 Daimler St, Santa Ana, CA, United States
Products
Sperm separation media are used to separate motile sperm from other constituents of semen.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2024Don't want to check this manually?
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