pTau 217 plasma controls recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls 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 pTau 217 Plasma Controls, model/catalog number 81558, are being recalled by Fujirebio Diagnostics, Inc. The record describes the product as a quality control product used as an objective judgement of laboratory procedures and personnel techniques.
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 148 units under UDI-DI 05414470815586, lot numbers D6C6092U, D6C6092U1 and D6C6123U. 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 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 personn
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Affected units
- 148
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 (5)
- Model/Catalog Number: 81558
- UDI-DI: 05414470815586
- Lot Numbers: D6C6092U
- D6C6092U1
- D6C6123U
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.
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