Fujirebio Diagnostics, Inc. Recall: Product Name: Lumipulse pTau 217 Plasma Controls Model
Fujirebio Diagnostics, Inc. Recall: Product Name: Lumipulse pTau 217 Plasma Controls Model is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Fujirebio Diagnostics, Inc.; Product: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable
| 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 p |
| 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington. |
| Recall initiated | 20251211 |
| Recall number | Z-1304-2026 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
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