pTau 217 plasma cartridges recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
What this means for you
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 G pTau 217 Plasma Immunoreaction Cartridges, model/catalog number 81550, is being recalled by Fujirebio Diagnostics, Inc. Where the enforcement record renders a Greek letter as an unreadable character, it is written here as 'beta'.
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 1,569 units under UDI-DI 05414470815500, with lot numbers recorded in the enforcement record. Distribution was nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine affected lots and follow Fujirebio's instructions.
The recalled product
- Product
- Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Affected units
- 1,569
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 (6)
- Model/Catalog Number: 81550
- UDI-DI: 05414470815500
- Lot Numbers: D4C6028U
- D4C6029U
- D4C6051U
- D4C6052U
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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