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TANBead Nucleic Acid Extraction Kit

Taiwan Advanced Nanotech INC. · Model M61G046 · UDI-DI 04719880122691

JJH
10
510(k) clearances
295
Adverse events (1 deaths)
32
Recalls
97
Facilities

Recalls

DateFirmReason
2026-09-11BioMerieux SADelayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to
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.

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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.