Direct Bilirubin, Total Bilirubin, Uric Acid, Triglycerides GPO Blanketed and Enzymatic Creatinine Reagents (2019-08-14)
- Starting date:
- August 14, 2019
- Posting date:
- September 12, 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-70957
Last updated: 2019-09-12
Affected Products
- Direct Bilirubin Reagent
- Total Bilirubin Reagent
- Uric Acid Reagent
- Triglycerides GPO Blanked Reagent
- Enzymatic Creatinine Reagent
Reason
Beckman Coulter has identified that n-acetyl p benzoquinone imine (NAQPI), a metabolite of acetaminophen (paracetamol), may cause negative interference for the following assays if present in high quantities in serum due to acetaminophen overdose:
- Enzymatic creatinine (PN A60298)
- Triglycerides gpo blanked (PN 445850)
- Uric acid (PN 442785)
- Direct bilirubin (PNs 439715 and 476856)
- Total bilirubin (PNs 442745 and 476861)
Affected products
A. Direct Bilirubin Reagent
Lot or serial number
All lots.
Model or catalog number
- 439715
- 476856
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Total Bilirubin Reagent
Lot or serial number
All lots.
Model or catalog number
- 442745
- 476861
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Uric Acid Reagent
Lot or serial number
All lots.
Model or catalog number
442785
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
D. Triglycerides GPO Blanked Reagent
Lot or serial number
All lots.
Model or catalog number
445850
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
E. Enzymatic Creatinine Reagent
Lot or serial number
All lots.
Model or catalog number
A60298
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES