FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse β-Amyloid Plasma Controls recalled for inaccurate Alzheimer's disease test results

FALSE CLAIMSNationwide distributionMedical devices Pet

What this means

Fujirebio is recalling quality control materials used in Alzheimer's disease testing labs. The controls may give falsely high or indeterminate results, causing patients to be incorrectly classified as having amyloid pathology or to receive unnecessary additional testing. This affects Model 81559, Lot T8B6116U, distributed in 13 U.S. states.

If you work in a laboratory using this product, stop using Lot T8B6116U immediately.
Contact Fujirebio Diagnostics for instructions on returning or disposing of the affected controls.
Review any test results generated using these controls with the manufacturer and your clinical team.

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

179 units

Manufactured in

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

Products

Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse ¿-Amyloid Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% 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-1307-2026

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