FDAFDA · Food and drugs·Recall number Z-0998-2024
Sperm separation media are used to separate motile sperm from other constituents of semen.
Published February 14, 2024 · Recall initiated: November 2, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
- Distributor
- 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
- Lot
- UDI-DI: 00857515006009, Lot 0000020693
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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