ARCHITECT BNP Controls (2019-05-29)

Starting date:

May 29, 2019

Posting date:

June 14, 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-70199

Last updated: 2019-06-14

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  Reason
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  Affected products

Affected Products

ARCHITECT BNP Controls

Reason

Falsely elevated patient and/or control results may be obtained when using ARCHITECT BNP calibrators and controls. Preliminary investigation 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