Plasma ratio test recalled over falsely elevated amyloid classification results
Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states falsely elevated results can incorrectly classify a patient as having amyloid pathology, and no injuries are reported.
Plain-English summary
Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio, model/catalog number CL0073, is being recalled by Fujirebio Diagnostics, Inc. Where the enforcement record renders a Greek letter as an unreadable character, it is written here as 'beta'.
The record states customers may experience inaccurate test results, observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio or PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results. The record states this causes an incorrect classification of a patient as having amyloid pathology associated with Alzheimer's disease, or as requiring more clinical testing.
The record lists 23 units under UDI-DI 00869164000086, with lot numbers recorded in the enforcement record. Distribution was nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine affected lots and follow Fujirebio's instructions.
The recalled product
- Product
- Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: CL0073
- UDI-DI: 00869164000086
- each consignee has 1 "Ratio" in which they purchase the component kits for.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Fujirebio Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Fujirebio Diagnostics, Inc.
See all →- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighpTau 217 plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11