Sperm separation media are used to separate motile sperm… recallZ-0998-2024 · Fujifilm Irvine Scientific, Inc. · initiated Nov 2, 2023
Class II Open, Classified All recalls posted in February 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fujifilm Irvine Scientific, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Mixed-up of materials/components
What the company is doing
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 [email protected] For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 [email protected]
Recall details
- Recall number
- Z-0998-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 2, 2023
- Posted by the FDA
- Feb 6, 2024
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Quantity
- 246
- Product code
- MQL
- FDA submissions
- K991341
- 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
Product description
Sperm separation media are used to separate motile sperm from other constituents of semen.
Code information (models, lots, serial numbers)
UDI-DI: 00857515006009, Lot 0000020693
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ISolate® 99264-2x100mLFujifilm Irvine Scientific, Inc. · Media, Reproductive1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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