Home › SEEGENE, INC. › Seegene STARlet

Seegene STARlet

SEEGENE, INC. · Model 1 · UDI-DI 08809240109007

JJH Prescription

510(k) clearances

294

Adverse events (1 deaths)

Recalls

Facilities

Description

a liquid pipetting system for analytical and clinical use

Recalls

Date	Firm	Reason
2024-06-03	Qiagen Sciences LLC	Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Pr
2024-03-04	Qiagen Sciences LLC	Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample b
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2022-11-02	Qvella Corporation	Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.