Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G -Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 1.5 mL (4 Concentrations) CAL 1 0 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL -Amyloid 1-42-N Plasma Calibrator 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

Recall number

Z-1306-2026

Recalling firm

Fujirebio Diagnostics, Inc.

Product

Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G -Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 1.5 mL (4 Concentrations) CAL 1 0 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL -Amyloid 1-42-N Plasma Calibrator 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

Status

Open, Classified

Initiated

2025-12-11

Posted

2026-02-05

Terminated

not on file

Reason

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).

Root cause

Under Investigation by firm

Action

On or about December 11, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken: - Immediately discontinue using the associated Lots listed above for the Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio. - Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. - Notify your ordering physician or health care provider as appropriate. - The test results must be interpreted in conjunction with other diagnostic tools and clinical information. - Please retain this letter with your laboratory records and forward this leer to those who may have received this product.

Quantity

128 units

Distribution

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

Lot, serial or model codes

Model/Catalog Number: 235454; UDI-DI: 04987270235454; Lot Numbers: D8C6022U, D8C6044U;

510(k) numbers

["K242706"]

PMA numbers

not on file

Product code

SET

Firm FEI

2521625

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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