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G-IVF PLUS

Vitrolife Sweden AB · Model 10136 · UDI-DI 07350025910550

MQL Prescription
10
510(k) clearances
24
Adverse events
15
Recalls
30
Facilities

Recalls

DateFirmReason
2024-02-16CooperSurgical, Inc.Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16CooperSurgical, Inc.Low concentration of sodium pyruvate in the wash could compromise gamete development
2024-02-16CooperSurgical, Inc.Low concentration of sodium pyruvate in the wash could compromise gamete development
2023-12-20CooperSurgical, 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.
2023-11-02Fujifilm 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
2023-02-13CooperSurgical, 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
2023-01-16Fujifilm Irvine Scientific, Inc.Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
2022-12-15CooperSurgical, 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.
2022-06-13CooperSurgical, 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
2021-09-08Fujifilm 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.