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chemagic 360-D

Wallac Oy · Model 2024-0010 · UDI-DI 06438147356706

JJH Prescription
10
510(k) clearances
295
Adverse events (1 deaths)
31
Recalls
99
Facilities

Description

The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.

Recalls

DateFirmReason
2024-06-03Qiagen Sciences LLCHeater 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
2024-03-04Qiagen Sciences LLCInsufficient 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
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2023-02-21Entopsis , Inc.Presence of misleading label statements on the product label.
2022-11-02Qvella CorporationDevice 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.