Recall record at a glance
| Official record | Z-1303-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Fujirebio Diagnostics, Inc. |
| Report date | Feb 11, 2026 |
| Recall initiation date | Dec 11, 2025 |
| Quantity | 117 units |
| Location | Malvern, PA, United States |
Official product description
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
Why the product was recalled
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).
Distribution information
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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