Medical Device Recall: Sperm separation media are used to separate motile sperm from other constituents of semen.
Fujifilm Irvine Scientific, Inc. · November 2, 2023
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
States Affected
AR, CA, DC, FL, IA, IL, IN, LA, MI, MN, NC, NJ, NV, NY, OK, OR, PA, TX, UT, WA, WI, WV
Quantity Affected
246
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0998-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.