--- title: "Fujirebio Diagnostics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Fujirebio Diagnostics, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fujirebio-diagnostics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Fujirebio Diagnostics, Inc. recall records **7** reported ongoing 7 records in this archive. Latest source date Dec 11, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-...](https://isitonrecall.com/recall/fda-device-z-1301-2026-product-name-lumipulse-g-ptau217-b-amyloid-1-42-plasma-ratio-model-catalog-number-cl0073-software-ve/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Softwa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1301-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma...](https://isitonrecall.com/recall/fda-device-z-1302-2026-product-name-lumipulse-g-ptau-217-plasma-immunoreaction-cartridges-model-catalog-number-81550-softwa/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1302-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: ...](https://isitonrecall.com/recall/fda-device-z-1303-2026-product-name-lumipulse-g-ptau-217-plasma-calibrators-model-catalog-number-81557-software-version-not/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Versio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1303-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quali...](https://isitonrecall.com/recall/fda-device-z-1304-2026-product-name-lumipulse-ptau-217-plasma-controls-model-catalog-number-81558-software-version-not-appl/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: No...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1304-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyl...](https://isitonrecall.com/recall/fda-device-z-1305-2026-product-name-lumipulse-g-amyloid-1-42-n-plasma-immunoreaction-cartridges-model-catalog-number-235447/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number:...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1305-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Pla...](https://isitonrecall.com/recall/fda-device-z-1306-2026-product-name-lumipulse-g-amyloid-1-42-n-plasma-calibrators-model-catalog-number-235454-software-vers/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Softwa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1306-2026%22) Dec 11, 2025 FDA device enforcement ### [Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This qua...](https://isitonrecall.com/recall/fda-device-z-1307-2026-product-name-lumipulse-amyloid-plasma-controls-model-catalog-number-81559-software-version-not-appli/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washing... [Official source for Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: N...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1307-2026%22) ## Reasons in these listed records - 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 ... These examples come from this result page and are not a ranking of every recall reason. ## Checking Fujirebio Diagnostics, Inc. ### Is there a recall on fujirebio diagnostics, inc. right now? This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Fujirebio Diagnostics, Inc.](https://isitonrecall.com/check/?q=Fujirebio%20Diagnostics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)