Z-0998-2024Class II

Sperm separation media are used to separate motile sperm from other constituents of semen

Name: Z-0998-2024 Sperm separation media are used to separate motile sperm from other constituents of semen
Creator: Fujifilm Irvine Scientific, Inc.
Published: 2023-11-02
License: https://open.fda.gov/license/

FUJIFILM Biosciences Inc. / initiated 2023-11-02 / Open, Classified

FDA source

Fujifilm Irvine Scientific, Inc. began a recall of Sperm separation media are used to separate motile sperm from other constituents of semen on 2023-11-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0998-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-02
Posted: 2024-02-06
Recalling firm: FUJIFILM Biosciences Inc.
Product: Sperm separation media are used to separate motile sperm from other constituents of semen.
Product code: MQL Media, Reproductive
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).
FDA 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 [email protected] For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 [email protected]
Quantity in commerce: 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
Product codes and lots: UDI-DI: 00857515006009, Lot 0000020693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0998-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0998-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code MQL

K991341Class IIIsolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. / cleared 1999-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)