Every recall we track for Fujirebio Diagnostics, Inc. — 7 in all — plus the complaints and injury reports the public filed about them.
Fujirebio recalls Lumipulse G pTau 217 plasma cartridges that may cause inaccurate Alzheimer's test results due to false positive or indeterminate readings. Affected units include specific model and lot numbers.
Fujirebio recalls Lumipulse G Amyloid 1-42 Plasma Calibrators (model 235454) due to potential inaccurate Alzheimer's test results. Affected users may get false positive or indeterminate results.
Fujirebio recalls Lumipulse G Amyloid 1-42 Plasma Immunoreaction Cartridges (Model 235447) due to potential inaccurate Alzheimer's disease test results. Affected users should contact the manufacturer for guidance.
Fujirebio recalls Lumipulse Amyloid Plasma Controls (model 81559) due to potential inaccurate Alzheimer's test results. Customers may get false positive or indeterminate results affecting diagnosis.
Fujirebio recalls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test kits (CL0073) that may produce inaccurate Alzheimer's disease results due to false positives. Affected users should contact Fujirebio for guidance.
Fujirebio recalls Lumipulse G pTau 217 Plasma Calibrators (model 81557) due to potential inaccurate Alzheimer's test results from false positive/indeterminate classifications. Affected units may need clinical retesting.
Fujirebio recalls Lumipulse pTau 217 Plasma Controls (model 81558) due to potential inaccurate Alzheimer's test results. Customers may get false positive or indeterminate results affecting diagnosis.
