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IntelliPrep TRIO 240 Sample Preparation System

PlexBio Co., Ltd. · Model 80042 · UDI-DI 04719882810046

JJH

510(k) clearances

294

Adverse events (1 deaths)

Recalls

Facilities

Description

The IntelliPrep TRIO 240 Sample Preparation System is designed for the combination use with dedicated IntelliPrep extraction kits to perform automated nucleic acids purification for assay setup. The extracted nucleic acids are intended for downstream molecular biology applications, not directly for the diagnosis, prevention, or treatment of a disease. The IntelliPrep TRIO 240 Sample Preparation System should be used by trained laboratory operators. The downstream diagnostic results obtained by using the extracted nucleic acid with this system should be interpreted in conjunction with clinical or laboratory data accordingly.

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

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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.