FDA Enforcement
Class II
Ongoing
Sperm separation media are used to separate motile sperm from other constituents of semen.
Recall: Z-0998-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0998-2024
- Event ID
- 93726
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fujifilm Irvine Scientific, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- November 2, 2023
- Classification Date
- February 6, 2024
- Address
- 2511 Daimler St, Santa Ana, CA, 92705-5533, United States
Description
Sperm separation media are used to separate motile sperm from other constituents of semen.
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 Info
UDI-DI: 00857515006009, Lot 0000020693
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
Quantity
246