| | Class 2 Device Recall ISolate, ISolate Concentrate, ISolate Stock Solution |  |
| Date Initiated by Firm | November 02, 2023 |
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| Date Posted | February 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0998-2024 |
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| Recall Event ID |
93726 |
| 510(K)Number | K991341 |
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| Product Classification |
Media, reproductive - Product Code MQL
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| Product | Sperm separation media are used to separate motile sperm from other constituents of semen. |
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| Code Information |
UDI-DI: 00857515006009, Lot 0000020693 |
| FEI Number |
2022379
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Recalling Firm/
Manufacturer |
Fujifilm Irvine Scientific, Inc.
2511 Daimler St
Santa Ana CA 92705-5533
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| For Additional Information Contact |
949-261-7800 |
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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). |
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FDA Determined
Cause 2 | Mixed-up of materials/components |
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| 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 fisira@fujifilm.com
For customers requiring furtherinformationorsupport, contact firm customer service at 1-800-577-6097 orfisitmrequest@fujifilm.com |
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| Quantity in Commerce | 246 |
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| 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
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = MQL
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