Amyloid plasma controls recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states falsely elevated results can incorrectly classify a patient as having amyloid pathology, and no injuries are reported.
Plain-English summary
Lumipulse beta-Amyloid Plasma Controls, model/catalog number 81559, are being recalled by Fujirebio Diagnostics, Inc. The Greek letter in the product name is rendered as an unreadable character in the enforcement record and is written here as 'beta'. The record describes the product as a quality control product used as an objective judgement of the laboratory's procedures and personnel techniques when analyzing beta-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System.
The record states customers may experience inaccurate test results, observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio or PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results. The record states this causes an incorrect classification of a patient as having amyloid pathology associated with Alzheimer's disease, or as requiring more clinical testing.
The record lists 179 units under UDI-DI 05414470815593, lot number T8B6116U. Distribution was nationwide in the United States across Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas and Washington. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow Fujirebio's instructions.
The recalled product
- Product
- Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and…
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Affected units
- 179
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: 81559
- UDI-DI: 05414470815593
- Lot Number: T8B6116U
Distribution
Part of a larger recall action
This product is one of 7 recalled by Fujirebio Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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