Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software… Recall
Issued February 11, 2026 · Fujirebio Diagnostics, Inc.
In February 2026, Fujirebio Diagnostics, Inc. recalled the Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fujirebio Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Fujirebio Diagnostics, Inc.
- Category
- Health
- Recall date
- February 11, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New
- Recall number
- FDA-Z-1304-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Fujirebio Diagnostics, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.