Sperm separation media are used to separate motile sperm from other constituents of semen.
- Company
- Fujifilm Irvine Scientific, Inc.
- Recall Initiated
- November 2, 2023
- Posted
- February 6, 2024
- Recall Number
- Z-0998-2024
- Quantity
- 246
- Firm Location
- Santa Ana, CA
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
Lot / Code Info
UDI-DI: 00857515006009, Lot 0000020693
Root Cause
Mixed-up of materials/components
Action Taken
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