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