Recall Z-0998-2024— Fujifilm Irvine Scientific, Inc.
Class II · Ongoing
Class II FDA medical device recall by Fujifilm Irvine Scientific, Inc., initiated 2023-11-02. It names one FDA 510(k) clearance: K991341. Product: 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)..
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-02
- Firm location
- Santa Ana, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.