FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse pTau 217 Plasma Controls recalled for inaccurate Alzheimer's disease test results

FALSE CLAIMSNationwide distributionMedical devices Pet

What this means

Fujirebio Diagnostics is recalling Lumipulse pTau 217 Plasma Controls (Model 81558) used in laboratory testing for Alzheimer's disease markers. The controls may produce falsely elevated results, leading labs to incorrectly classify patients as having Alzheimer's disease or requiring additional testing.

If your laboratory uses this product, stop using affected lot numbers D6C6092U, D6C6092U1, and D6C6123U immediately.
Contact Fujirebio Diagnostics for instructions on returning the product and obtaining replacements.
Review any patient test results from affected lot numbers with your healthcare provider or laboratory director.

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

148 units

Manufactured in

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

Products

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 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 pTau 217 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 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-1304-2026

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