Health product recall

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

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

Alinity i BNP Calibrators

Lot or serial number

Contact manufacturer.

Model or catalog number

08P2401

Companies
Manufacturer

Abbott GMBH & Co. K.G.

MAX PLANCK RING 2

WIESBADEN

65205

GERMANY