Sperm Separation Media (Fujifilm) – component mismatch (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sperm separation media are used to separate motile sperm from other constituents of semen.
Brand
Fujifilm Irvine Scientific, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00857515006009, Lot 0000020693
Products Sold
UDI-DI: 00857515006009, Lot 0000020693
Fujifilm Irvine Scientific, Inc. is recalling Sperm separation media are used to separate motile sperm from other constituents of semen. due to The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, S. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 11/2/23, recall notices were distributed to customers who were asked to do the following: 1) Review inventory and if the lower layer is incorrect, per the COA, stopusingtheFISIProduct,return/destroyit,andrequestareplacementorcredit. 2)ThisnoticeneedstobepassedontoallthosewhoneedtobeawarewithinyourorganizationortoanyorganizationwherethepotentiallyaffectedProducthasbeentransferred. 2) Complete and return the return response form via email to fisira@fujifilm.com For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 orfisitmrequest@fujifilm.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, FL, IL, IN, IA, LA, MI, MN, NV, NJ, NY, NC, OK, OR, PA, TX, UT, WA, WV, WI, DC
Page updated: Jan 10, 2026