# FDA recall Z-1302-2026

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

## Product

Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges  Model/Catalog Number: 81550  Software Version: Not Applicable  Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC):  Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System.    3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC.  Each IRC contains (abbreviated contents):   1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower,   2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate),   3. Assay Specific Solu

## 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-1302-2026
- **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-1302-2026

## Citation

> AI Analytics. FDA recall Z-1302-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1302-2026. Source: US FDA. Licensed CC0.

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