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U.S. Department of Health and Human Services

Class 2 Device Recall ISolate, ISolate Concentrate, ISolate Stock Solution

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  Class 2 Device Recall ISolate, ISolate Concentrate, ISolate Stock Solution see related information
Date Initiated by Firm November 02, 2023
Date Posted February 06, 2024
Recall Status1 Open3, Classified
Recall Number Z-0998-2024
Recall Event ID 93726
510(K)Number K991341  
Product Classification Media, reproductive - Product Code MQL
Product Sperm separation media are used to separate motile sperm from other constituents of semen.
Code Information UDI-DI: 00857515006009, Lot 0000020693
Recalling Firm/
Manufacturer		 Fujifilm Irvine Scientific, Inc.
2511 Daimler St
Santa Ana CA 92705-5533
For Additional Information Contact
949-261-7800
Manufacturer 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 Determined
Cause 2		 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, stop¿using¿the¿FISI¿Product,¿return/destroy¿it,¿and¿request¿a¿replacement¿or¿credit. 2)This¿notice¿needs¿to¿be¿passed¿on¿to¿all¿those¿who¿need¿to¿be¿aware¿within¿your¿organization¿or¿to¿any¿organization¿where¿the¿potentially¿affected¿Product¿has¿been¿transferred. 2) Complete and return the return response form via email to fisira@fujifilm.com¿¿ For customers requiring further¿information¿or¿support, contact firm customer service at 1-800-577-6097 or¿fisitmrequest@fujifilm.com
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQL and Original Applicant = IRVINE SCIENTIFIC SALES CO., INC.
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