Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Due to Inaccurate Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse G pTau 217 Plasma Immunoreaction Cartridges. The recall was prompted by reports of inaccurate test results, where users observed a higher frequency of classification in the indeterminate and positive zones. These falsely elevated ratios can lead to an incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease or result in unnecessary additional clinical testing when compared to FDA-cleared CSF ratio or PET imaging.

Which Products Are Affected

The recall affects 1,569 units of the following diagnostic product:

• Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
• Model/Catalog Number: 81550
• UDI-DI: 05414470815500
• Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U
• Recall Number: Z-1302-2026

Distribution was nationwide within the United States, specifically reaching the following states: Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.

What You Should Do

The firm initiated the recall via a notification letter sent to affected customers. Laboratories and healthcare facilities possessing the specified lot numbers should follow the instructions provided in the firm’s notification. For further inquiries regarding the return or replacement of these cartridges, contact Fujirebio Diagnostics, Inc. at their Malvern, Pennsylvania headquarters.

Why This Matters

This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of Alzheimer’s disease pathology, potentially causing patients to undergo further invasive testing or receive incorrect clinical management.

Source

Information provided by the FDA.