SpermAlign

CYTOSWIM LTD · Model CYT 001 · UDI-DI 15070002516207

MQK Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

SpermAlign is a passive microfluidic device that separates sperm based on their motility. Separation is achieved through a defined microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilises a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and with media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure.

Recalls

Date	Firm	Reason
2022-04-01	CooperSurgical, Inc.	Products in this lot may have compromised barrier seals, introducing a risk to sterility.
2014-06-20	ORIGIO, Inc	Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
2011-11-28	ORIGIO HUMAGEN PIPETS INC.	Cryopettes were rupturing during the warming process following vitrification.
2007-05-08	Humagen 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.