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MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit

THERMO FISHER SCIENTIFIC BALTICS UAB · Model A48383 · UDI-DI 10190302018241

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-10-28	Illumina, Inc.	An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality i
2018-04-26	Horiba Instruments, Inc dba Horiba Medical	When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of

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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.