Z-0998-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- November 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246
Product Description
Sperm separation media are used to separate motile sperm from other constituents of semen.
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 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
Code Information
UDI-DI: 00857515006009, Lot 0000020693