Lipase OSR6x30, Uric Acid OSR6x98, and Enzymatic Creatinine OSR6x204 (2018-08-27)
- Starting date:
- August 27, 2018
- Posting date:
- September 17, 2018
- 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-67756
Affected products
A. Lipase OSR6x30
B. Uric Acid OSR6x98
C. Enzymatic Creatinine OSR6x204
Reason
NAPQI (N-Acetyl-p-benzoquinone imine), a metabolite of Acetaminophen, causes negative interference with enzymatic creatinine OSR6X204, Lipase OSR6X30 and uric acid OSR6x98 assays, at levels present in the serum/plasma of overdose patients. NAPQI in toxic concentrations may potentially lead to erroneously low results for enzymatic creatinine, lipase and uric acid.
Affected products
A. Lipase OSR6x30
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OSR6X30
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. Uric Acid OSR6x98
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OSR6X98
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
C. Enzymatic Creatinine OSR6x204
Lot or serial number
1508
2431
2433
2434
2436
2438
2441
Model or catalog number
OSR6X204
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES