Fujifilm Irvine Scientific recalls sperm separation kits with incorrect lot numbers that may lead to inaccurate sperm analysis results. Affected kits contain wrong lower layer components as per certificate of analysis.
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).
Fujifilm Irvine Scientific is recalling sperm separation kits that may have incorrect lower layer components. This could lead to inaccurate sperm analysis results if used in fertility testing.
The lower layer component in the kit does not match the certificate of analysis. This means the kit may contain the wrong lot number (9925811106) instead of the correct one (0000020686), potentially causing inaccurate sperm analysis results.
People using sperm separation kits for fertility testing may be affected. Those who have kits with the incorrect lot numbers (0000020686 or 9925811106) are most at risk.
Check the lower layer lot number on the kit. Correct kits should have lot number 0000020686 with shelf life until December 31, 2024. Incorrect kits may have lot number 9925811106 with shelf life until November 30, 2023.
Look for the lower layer lot number on the kit. Correct kits should have lot number 0000020686 with shelf life until December 31, 2024.
The lower layer component does not match the certificate of analysis. The kit may contain the wrong lot number (9925811106) instead of the correct one (0000020686).
Check the lower layer lot number. If it's 0000020686 with shelf life until December 31, 2024, it's safe. If it's 9925811106 with shelf life until November 30, 2023, contact Fujifilm Irvine Scientific for a replacement.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Fujifilm Irvine Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0998-2024 — Fujifilm Irvine Scientific Fujifilm Irvine Scientific Hello, I own a Fujifilm Irvine Scientific that is covered by recall Z-0998-2024 from Fujifilm Irvine Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
