Sperm separation media are used to separate motile sperm from other constituents of semen.
This recall is currently active, issued February 6, 2024. It was issued by Fujifilm Irvine Scientific, Inc..
- 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
- Official Source
- View on FDA website ↗
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