Sperm separation media are used to separate motile sperm from other constituents of semen.
FDA device recall Z-0998-2024 · posted 2024-02-06 · Open, Classified
Recall details
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- 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).
- 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
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- MQL
- Quantity affected
- 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
- Date initiated
- 2023-11-02
- Date posted
- 2024-02-06
- Location
- Santa Ana, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION (K991341) | Irvine Scientific Sales Co., Inc. | 1999-07-08 |