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RADI Extractor 32

KH Medical Co., Ltd. · Model OE005 · UDI-DI 08800204300133

JJH

510(k) clearances

295

Adverse events (1 deaths)

Recalls

Facilities

Description

RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 32 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 32 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.

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.