Alere NT-proBNP for ARCHITECT Controls & Calibrators (2020-02-26)
- Starting date:
- February 26, 2020
- Posting date:
- May 1, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72915
Last updated: 2020-05-01
Affected Products
A. Alere NT-proBNP for ARCHITECT Controls
B. Alere NT-proBNP for ARCHITECT Calibrators
Reason
Between February 4th, 2020 and March 5th 2020, a total of fourteen (14) complaints were received reporting problems with calibration of the Alere NT-proBNP assay resulting in elevation of test results; patient samples, EQA samples and third-party controls.
Affected products
A. Alere NT-proBNP for ARCHITECT Controls
Lot or serial number
- 902929465
- 902929899
Model or catalog number
- 2R10-10
Companies
- Manufacturer
-
Axis-Shield Diagnostics Limited
The Technology Park
Dundee
DD2 1XA
UNITED KINGDOM
B. Alere NT-proBNP for ARCHITECT Calibrators
Lot or serial number
- 902929466
- 902929915
Model or catalog number
- 2R10-01
Companies
- Manufacturer
-
Axis-Shield Diagnostics Limited
The Technology Park
Dundee
DD2 1XA
UNITED KINGDOM