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Recall Observatory FDA recall evidence

Device product

Sperm separation media are used to separate motile sperm from other constituents of semen.

Z-0998-2024

November 02, 2023

Class II

Product summary

Firm
Fujifilm Irvine Scientific, Inc.
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

    reason.no_named_rule · v1.0.0

    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).