Every recall we track for Luminex Corporation — 38 in all — plus the complaints and injury reports the public filed about them.
Luminex recalls VERIGENE Gram Negative Blood Culture test cartridges due to potential false negatives in small portions of the lot. Affected units have specific lot numbers and expiration dates.
Luminex recalls Verigene Gram Positive Blood Culture test cartridges that may cause false positives for Staphylococcus lugdunensis and Enterococcus faecium. Affected units have specific lot numbers and expiration dates.
Luminex recalls 5-pack utility trays for Gram-Positive Blood Culture tests due to potential defects causing test errors. Affected units include specific lot numbers and expiration dates.
Luminex recalls specific Verigene Enteric Pathogens Nucleic Acid Test kits that may give false-negative results due to hydrophobic FLOQSwab lots. Affected units include certain lot numbers from 2022-2023.
Luminex recalls specific VERIGENE C. diff test kits that may give false negative results due to hydrophobic characteristics in certain FLOQSwab lots. Affected kits have lot numbers 071222022D and 100622022D.
Luminex recalls ARIES SARS-CoV-2 Assay kits with specific lot numbers due to potential false negative results from a wash 1 syringe defect.
Luminex recalls ARIES SARS-CoV-2 Assay (Lot AB4042A) due to potential false negatives from missed ORF1ab gene detection. Consumers should verify test results with a different test.
Luminex recalls Verigene CDF Nucleic Acid Test kits with potential for false negative results due to swab hydrophobicity. Affected kits include specific lot numbers and model parts.
Luminex recalls specific VERIGENE Enteric Pathogens Nucleic Acid Test kits that may produce false negative results due to swab hydrophobic characteristics. Affected kits include certain Luminex and FLOQSwab lot numbers.
Luminex recalls Verigene Processor SP models 10-0000-07/10-0000-07R due to potential false negative results from temperature issues in the Verigene system.
Luminex recalls specific VERIGENE Nucleic Acid Test Kit extraction trays due to potential no call internal control failures from missing reagents. Affected units include lot 101321021B.
Luminex recalls ARIES HSV 1&2 Assay (lot AB3600A, AB356: 0.9% leak rate may cause incorrect test results or delayed reporting due to invalid results.
Luminex recalls Verigene EP Amplification Reagent Kit Test with potential for false positive results. Affected lots include specific model numbers and dates. Consumers should check their kit's lot number and contact Luminex for details.
Luminex recalls ARIES HSV 1&2 Assay (part 50-10017) due to potential internal leaks. Affected units sold with lot AB1703A. Stop using if leaking.
Luminex Corporation recalls VERIGENE Processor SP devices with specific serial numbers due to potential false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella. Affected units may not detect these pathogens correctly when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Luminex recalls Verigene Gram-Positive Blood Culture Nucleic Acid Test (Model 20-006-018) due to potential false-negative results. Affected units sold from 2020-03-06 to 2020-09-01.
Luminex recalls Verig: Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model 20-006-026 due to potential false-negative results. Affected units may not detect infections accurately.
Luminex recalls Verigene C. diff test kits with model numbers 20-006-022, 041520022A, 061920022A, and 081120022A due to potential false negatives. Consumers should check their kit model and contact Luminex for details.
Luminex recalls Verigene Enteric Pathogens Nucleic Acid Test Model 20-006-023 due to potential false-negative results. Affected units may not detect infections accurately.
Luminex recalls Verigene Gram Negative Blood Culture Nucleic Acid Test (Model 20-006-021) due to potential false negatives. Affected units may not detect infections accurately.
Luminex recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model 20-006-024 due to potential false-negative results. Consumers should check product codes for affected units.
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Negative Blood tests due to unapproved test fixtures causing calibration errors. Affected units have specific serial numbers listed in the recall.
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Positive Blood tests due to unapproved test fixtures causing calibration errors. Affected units have specific serial numbers listed in the recall.
Luminex recalls Verigene Processor SP devices with specific serial numbers that may produce false negative results for Gram-positive blood culture tests. Affected units include those with serial numbers listed in the recall notice.
Luminex recalls Verigene Processor SP devices with specific serial numbers that may produce false negative results for Gram-Negative Blood Culture tests, potentially leading to missed infections. Affected units include those with serial numbers listed in the recall.
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07-R due to repeated No Call results. Affected units have specific serial numbers listed in the recall notice.
Luminex recalls ARIES Extraction Kit and ARIES System with partial seal in side cassette assemblies that may cause reduced solution volume and assay instability. Affected units include specific lot numbers with deadlines for discontinuation.
Luminex recalls Aries Bordetella Assay (REF 50-10037) due to partial seal in side cassette assemblies potentially causing assay inaccuracies. Affected units include specific lot numbers with immediate discontinuation needed.
Luminex recalls ARIES Group A Strep Assay (REF 50-10041) due to partial seal in side cassette assemblies potentially causing assay inaccuracies. Affected units include specific lot numbers with discontinuation dates.
Luminex recalls ARIES GBS Assay (REF 50-10021) due to potential partial sealing of side cassette assemblies, which may cause reduced solution volume and assay instability. Affected units include specific lot numbers with discontinue dates.
Luminex recalls ARIES Flu A/B & RSV Assay (REF 50-10020) due to potential partial seal in side cassette assemblies causing assay inaccuracies. Affected units include specific lot numbers with discontinuation dates.
Luminex recalls ARIES C. difficile Assay (REF 50-10018) due to potential partial seal in side cassette assemblies, which may decrease assay sensitivity or stability. Affected units include specific lot numbers with discontinue dates.
Luminex recalls ARIES HSV 1&2 Assay (REF 50-10017) due to potential partial sealing of side cassette assemblies, which may decrease solution volume and assay sensitivity. Affected units include specific lot numbers with discontinuation dates.
Luminex recalls Vergene Amplification Tray (700uL, BC-GP REF 20-011-018) due to labeling error on Verigene Gram-Positive Blood Culture Nucleic Acid Test kits. Affected units have specific UDI and lot numbers.
Luminex recalls VERIGENE Processor SP Model 10-0000-07 due to potential incorrect test results from hybridization heater failure. Affected units may need repair or replacement.
Luminex recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) due to potential false negative results in bacterial detection tests. Affected units include specific supplier and utility tray lots.
Luminex recalls Aries M1 System software v1.0 for in vitro diagnostics due to potential patient sample mismatches and duplicate results. Affected units have specific scanner labels and were sold after April 2017.
Luminex recalls Verigene Enteric Pathogens Nucleic Acid Test kits with specific cartridge model due to risk of false Yersinia enterocolitica results. Affected units include lot 032718023A.
