# FDA recall Z-1304-2026

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

## Product

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

## 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-1304-2026
- **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-1304-2026

## Citation

> AI Analytics. FDA recall Z-1304-2026. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1304-2026. Source: US FDA. Licensed CC0.

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