ARCHITECT BNP Calibrators and 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-70203
Last updated: 2019-06-14
Affected Products
A. ARCHITECT BNP Calibrators
B. ARCHITECT BNP Controls
Reason
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
A. ARCHITECT BNP Calibrators
Lot or serial number
- 44K79418
- 44K79518
- 44K81018
- 44K81118
- 44K82018
- 44K82818
- 44K84119
- 44K84219
- 44K85219
Model or catalog number
8K28-03
Companies
- Manufacturer
-
Abbott GMBH & Co. K.G.
MAX PLANCK RING 2
WIESBADEN
65205
GERMANY
B. ARCHITECT BNP Controls
Lot or serial number
44K79518
44K81118
44K82818
44K84219
Model or catalog number
8K28-12
Companies
- Manufacturer
-
Abbott GMBH & Co. K.G.
MAX PLANCK RING 2
WIESBADEN
65205
GERMANY