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Geri Dish

GENEA BIOMEDX PTY LTD · Model GERI-DSH-20 · UDI-DI 09348265003017

MQK Prescription
1
510(k) clearances
2
Adverse events
4
Recalls
55
Facilities

Description

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

Recalls

DateFirmReason
2022-04-01CooperSurgical, Inc.Products in this lot may have compromised barrier seals, introducing a risk to sterility.
2014-06-20ORIGIO, IncIdentification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
2011-11-28ORIGIO HUMAGEN PIPETS INC.Cryopettes were rupturing during the warming process following vitrification.
2007-05-08Humagen Fertility Diagnostics, Inc.Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

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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.