FDA Medical Device Recalls (openFDA)
Fujifilm Irvine Scientific, Inc.: Sperm separation media are used to separate motile sperm from other constituents of semen.
- Recall number
- Z-0998-2024
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Product
- Sperm separation media are used to separate motile sperm from other constituents of semen.
- Status
- Open, Classified
- Initiated
- 2023-11-02
- Posted
- 2024-02-06
- Terminated
- not on file
- 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).
- Root cause
- Mixed-up of materials/components
- Action
- On 11/2/23, recall notices were distributed to customers who were asked to do the following: 1) Review inventory and if the lower layer is incorrect, per the COA, stopusingtheFISIProduct,return/destroyit,andrequestareplacementorcredit. 2)ThisnoticeneedstobepassedontoallthosewhoneedtobeawarewithinyourorganizationortoanyorganizationwherethepotentiallyaffectedProducthasbeentransferred. 2) Complete and return the return response form via email to fisira@fujifilm.com For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 orfisitmrequest@fujifilm.com
- Quantity
- 246
- 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
- Lot, serial or model codes
- UDI-DI: 00857515006009, Lot 0000020693
- 510(k) numbers
- ["K991341"]
- PMA numbers
- not on file
- Product code
- MQL
- Firm FEI
- 2022379
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28