Z-1304-2026Class II

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable...

Name: Z-1304-2026 Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable...
Creator: Fujirebio Diagnostics, Inc.
Published: 2025-12-11
License: https://open.fda.gov/license/

Fujirebio Diagnostics, Inc. / initiated 2025-12-11 / Open, Classified

FDA source

Fujirebio Diagnostics, Inc. began a recall of Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma... on 2025-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1304-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-11
Posted: 2026-02-05
Recalling firm: Fujirebio Diagnostics, Inc.
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
Product code: SET Immunoassay Blood Test For Amyloid Pathology Assessment
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).
FDA root cause: Under Investigation by firm
Action: On or about December 11, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken: - Immediately discontinue using the associated Lots listed above for the Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio. - Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. - Notify your ordering physician or health care provider as appropriate. - The test results must be interpreted in conjunction with other diagnostic tools and clinical information. - Please retain this letter with your laboratory records and forward this leer to those who may have received this product.
Quantity in commerce: 148 units
Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Product codes and lots: Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1301-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1302-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1303-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1304-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1305-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1306-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1307-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

Product code SET

K242706Class IILumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. / cleared 2025-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)