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Luminex Corporation

18 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use wi recall (Z-1903-2025)Luminex Corporation2025-06-03
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test recall (Z-2533-2024)Luminex Corporation2024-08-08
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic recall (Z-0500-2024)Luminex Corporation2023-12-06
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 recall (Z-2023-2023)Luminex Corporation2023-06-28
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 recall (Z-2024-2023)Luminex Corporation2023-06-28
ARIES SARS-CoV-2 Assay, REF: 50-10047 recall (Z-0134-2023)Luminex Corporation2022-10-26
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system recall (Z-1092-2022)Luminex Corporation2022-05-13
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use recall (Z-2292-2019)Luminex Corporation2019-08-19
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 recall (Z-2282-2019)Luminex Corporation2019-08-15
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 recall (Z-2283-2019)Luminex Corporation2019-08-15
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 recall (Z-2284-2019)Luminex Corporation2019-08-15
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 recall (Z-2285-2019)Luminex Corporation2019-08-15
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 recall (Z-2286-2019)Luminex Corporation2019-08-15
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 recall (Z-2287-2019)Luminex Corporation2019-08-15
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073 recall (Z-2288-2019)Luminex Corporation2019-08-15
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blo recall (Z-0822-2019)Luminex Corporation2019-02-11
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Pr recall (Z-0445-2019)Luminex Corporation2018-11-10
xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnosti recall (Z-3112-2011)Luminex Corporation2011-08-31

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Every clearance here is in the API, with alerts when new ones post.