Recall Z-0998-2024 ยท MQL Media, Reproductive
Fujifilm Irvine Scientific, Inc.
Sperm separation media are used to separate motile sperm from other constituents of semen.
| Date | Feb 6, 2024 (initiated Nov 2, 2023) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 246 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION Irvine Scientific Sales Co., Inc., Jul 8, 1999 |