CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
Lumipulse pTau 217 Plasma Controls recalled by Fujirebio Diagnostics
Fujirebio Diagnostics is recalling Lumipulse pTau 217 Plasma Controls, distributed nationwide in the US. The recall was initiated on 11 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1304-2026
- FDA event ID
- 98232
- Recalling firm
- Fujirebio Diagnostics, Malvern, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2025
- FDA classified
- 5 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 11 Dec 2025 | Recall initiated by company | |
| 5 Feb 2026 | Classified by FDA | +56 days |
| 11 Feb 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Nationwide ArizonaCaliforniaFloridaIndianaKansasKentuckyMassachusettsMarylandMinnesotaNew JerseyPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;
Where was it sold?
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98232| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lumipulse G pTau 217 Plasma Calibrators recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics | Fujirebio Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide |
More recalls from Fujirebio Diagnostics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics | Fujirebio Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio recalled | Fujirebio Diagnostics | Labeling Errors | Nationwide |
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