ADVIA Centaur NT-proBNP (PBNP) (2019-12-24)

Starting date:

December 24, 2019

Posting date:

January 24, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72173

Last updated: 2020-01-24

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  Reason
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  Affected products

Affected Products

ADVIA Centaur NT-proBNP (PBNP)

Reason

Siemens Healthcare Diagnostics Inc. confirmed an average method comparison bias of up to 20% with ADVIA Centaur NT-proBNP (PBNP) Assay kit. Siemens’ investigation verified that the ADVIA Centaur PBNP assay continues to meet the reference intervals listed in the ADVIA Centaur PBNP Instructions for Use (IFU) and concordance (agreement) to the predicate method is greater than or equal to 95%. Siemens is currently investigating root cause of the method comparison bias observed and will send a follow-up communication when further information is available.

Affected products