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Oocyte Retrieval Buffer

GENEA BIOMEDX PTY LTD · Model ORB-20 · UDI-DI 09348265004076

MQL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes. This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10^-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.

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.