Luminex Recalls
39 recalls on record · May 24, 2017 to June 11, 2025 · Medical Devices
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
February 20, 2019Medical DevicesFDA
Luminex Corporation recalls Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Tes
Hazard: On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
November 21, 2018Medical DevicesFDA
Luminex Corporation recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro di
Hazard: Potential to lead to a false negative results.
September 5, 2018Medical DevicesFDA
Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viru
Hazard: Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
May 24, 2017Medical DevicesFDA
Luminex Corporation recalls ARIES System and ARIES M1 System
Hazard: The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.