FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse G pTau 217 Plasma Calibrators recalled for inaccurate Alzheimer's test results

FALSE CLAIMSNationwide distributionMedical devices Pet

What this means

Fujirebio Diagnostics' Lumipulse G pTau 217 Plasma Calibrators (Model 81557) may produce inaccurate test results, causing patients to be incorrectly classified as having Alzheimer's-related amyloid pathology or flagged for unnecessary additional testing. The calibration issue leads to falsely elevated results that do not match established imaging and CSF tests.

Stop using affected calibrator lots D5C6094U and D5C6125U immediately
Contact Fujirebio Diagnostics for replacement calibrators or instructions
Review recent patient test results from these lots with your laboratory director
Notify patients who received results using these calibrators if recommended by your lab

The agency's original wording

Hazard

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Intended for

Adults

Illnesses reported

None reported

Sold states

US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.

Affected count

117 units

Manufactured in

201 Great Valley Pkwy, N/A, Malvern, PA, United States

Products

Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2026

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