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

Date

Feb. 14, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Fujifilm Irvine Scientific, Inc.

Product

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

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).

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

Quantity

246

Codes and lots

UDI-DI: 00857515006009, Lot 0000020693

Recall started

Nov. 2, 2023

Device type

Media, Reproductive

Root cause (FDA)

Mixed-up of materials/components

What the company told customers

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

Recall number

Z-0998-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0998-2024. The agency record governs; check it and the company before acting.