Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators… — Class II medical device recall Z-1306-2026
Ongoing recall by Fujirebio Diagnostics, Inc., reported 2026-02-11, distributed nationwide. Customers may experience inaccurate test results by observing a higher frequency of classification in the inde
| Recall number | Z-1306-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujirebio Diagnostics, Inc., Malvern, PA, United States |
| Recall initiated | 2025-12-11 |
| Classified | 2026-02-05 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 128 units |
| UPC / GTIN / UDI-DI | 04987270235454 |
| Lot numbers | D8C6022U, D8C6044U |
| Model numbers | 235454 |
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1306-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.