Alinity i BNP Calibrators (2019-05-28)

Starting date:

May 28, 2019

Posting date:

June 21, 2019

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-70237

Last updated: 2019-06-21

• Reason
• Affected products

Affected Products

Alinity i BNP Calibrators

Reason

Falsely elevated patient and/or control results may be obtained when using Alinity i BNP calibrators and controls. Preliminary investigation performed at Fujirebio has determined that all current in-date BNP calibrator and control lots are impacted by an age dependent shift in performance. Use of impacted calibrator lots may result in falsely elevated patient results. Use of impacted control lots may result in invalid patient results due to controls out of range.

Affected products