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SSS-NX (Serum Substitute Supplement-NX)

FUJIFILM IRVINE SCIENTIFIC, INC. · Model 90194 12x10 mL · UDI-DI 00857515006641

MQL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

SSS-NX Serum Substitute Supplement-N consists of human serum albumin and human serum globulins in saline solution and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for culture medium.

Recalls

Date	Firm	Reason
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16	CooperSurgical, Inc.	Low concentration of sodium pyruvate in the wash could compromise gamete development
2023-12-20	CooperSurgical, Inc.	The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
2023-11-02	Fujifilm Irvine Scientific, Inc.	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) b
2023-02-13	CooperSurgical, Inc.	It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source
2023-01-16	Fujifilm Irvine Scientific, Inc.	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
2022-12-15	CooperSurgical, Inc.	The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
2022-06-13	CooperSurgical, Inc.	There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct
2021-09-08	Fujifilm Irvine Scientific, Inc.	Due to a component in kit being labeled with the incorrect Expiration Date

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.