ADVIA Centaur NT-proBNP (PBNP) & Atellica IM NT-proBNP (PBNP) (2020-03-05)

Starting date:

March 5, 2020

Posting date:

May 8, 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-72989

Last updated: 2020-05-08

• 
  Reason
• 
  Affected products

Affected Products

1. ADVIA Centaur NT-proBNP (PBNP)
2. Atellica IM 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 kits and an average method comparison regression bias of up to 13% with Atellica IM NT-proBNP (PBNP) Assay kits. Siemens' investigation verified that the ADVIA Centaur PBNP and Atellica IM PBNP Assays continue to meet the reference intervals listed in the ADVIA Centaur PBNP and Atellica IM 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