Health product recall

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