proBNP II STAT Calset and proBNP II Calibrator (2018-06-14)
- Starting date:
- June 14, 2018
- Posting date:
- June 29, 2018
- 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-67136
Affected products
- proBNP II STAT Calset
- proBNP II Calibrator
Reason
Increased QC recovery and/or re-calibration issues due to signal drift, when the proBNP II calibrator lots 221122 and 288039 or proBNP STAT Calibrator lots 221133 and 288040 are used after being stored at 2-8 degrees Celsius after reconstitution.
Affected products
A. proBNP II STAT Calset
Lot or serial number
- 22113301
- 28804001
Model or catalog number
- 05390117190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. proBNP II Calibrator
Lot or serial number
- 22112201
- 22112202
- 28803901
Model or catalog number
- 04842472190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY