pTau 217 plasma calibrators recalled over falsely elevated ratio results

Plain-English summary

Lumipulse G pTau 217 Plasma Calibrators, model/catalog number 81557, 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 117 units under UDI-DI 05414470815579, 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 Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu

Manufacturer

Fujirebio Diagnostics, Inc.

Category

Medical Device — In vitro diagnostic

Hazard

• false-positive
• amyloid-testing
• alzheimers-testing

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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