# FDA recall Z-1301-2026

> **Fujirebio Diagnostics, Inc.** · Class II · device recall initiated 2025-12-11.

## 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 G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid

## Reason for recall

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

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

## Key facts

- **Recall number:** Z-1301-2026
- **Recalling firm:** Fujirebio Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-11
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2026

## Citation

> AI Analytics. FDA recall Z-1301-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1301-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*