Sperm separation media are used to separate motile sperm from other constituents of semen.
FDA Recall Z-0998-2024 · Posted 2024-02-06
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Recalling FirmFujifilm Irvine Scientific, Inc.
Recall StatusOpen, Classified
Product CodeMQL
Date Initiated2023-11-02
Product Quantity246
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).
Firm 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 [email protected]
For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 [email protected]
Root Cause
Mixed-up of materials/components
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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