# FDA recall Z-1303-2026

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

## Product

Product Name: Lumipulse G pTau 217 Plasma Calibrators  Model/Catalog Number: 81557  Software Version: Not Applicable  Product Description: Lumipulse G pTau 217 Plasma Calibrators:  The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in  pg/mL.  Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen),  1x1.5 mL (5 Concentrations)  CAL 1             0 pg/mL pTau 217 Plasma Calibrator  CAL 2     0.250 pg/mL pTau 217 Plasma Calibrator  CAL 3     1.000 pg/mL pTau 217 Plasma Calibrator  CAL 4     5.000 pg/mL pTau 217 Plasma Calibrator  CAL 5   10.000 pg/mL pTau 217 Plasma Calibrator  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-1303-2026
- **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-1303-2026

## Citation

> AI Analytics. FDA recall Z-1303-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1303-2026. Source: US FDA. Licensed CC0.

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