Device product
Sperm separation media are used to separate motile sperm from other constituents of semen.
Z-0998-2024
Product summary
- Event
- Event 93726
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 246
- Official record key
device-enforcement:Z-0998-2024
Official wording
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).
Code information: UDI-DI: 00857515006009, Lot 0000020693
Distribution pattern: 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
Derived failure modes
-
Unknown
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).