Amyloid 1-42-N plasma calibrators recalled over falsely elevated results
Fujirebio Diagnostics is recalling 128 units of Lumipulse G beta-Amyloid 1-42-N Plasma Calibrators 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 beta-Amyloid 1-42-N Plasma Calibrators, model/catalog number 235454, are 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 128 units under UDI-DI 04987270235454, lot numbers D8C6022U and D8C6044U. 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 ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Affected units
- 128
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 (4)
- Model/Catalog Number: 235454
- UDI-DI: 04987270235454
- Lot Numbers: D8C6022U
- D8C6044U
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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