This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Acetaminophen Assays (2015-05-05)
- Starting date:
- May 5, 2015
- Posting date:
- June 15, 2015
- 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-53777
Recalled Products
- Acetaminophen-SL Assay
- Muligent Acetaminophen Assay
Reason
Sekisui Diagnostics has issued a field correction for the acetaminophen assay, catalog number 2k99-20, 505-10 and 505-30, because the interference for n-acetylcysteine (NAC) has increased (resulting in a larger negative bias in acetaminophen concentration), relative to the level reported in the reagent package insert.
Affected products
A. Acetaminophen-SL Assay
Lot or serial number
- 45468
- 45844
- 46098
- 46358
Model or catalog number
- 505-10
- 505-30
Companies
- Manufacturer
-
Sekisui Diagnostics P.E.I. Inc.
70 Watts Avenue
Charlottetown
C1E 2B9
Prince Edward Island
CANADA
B. Muligent Acetaminophen Assay
Lot or serial number
- 45797UQ04
- 46121UQ07
- 46207UQ09
- 46561UQ08
- 46953UQ12
Model or catalog number
- 2K99-20
Companies
- Manufacturer
-
Sekisui Diagnostics P.E.I. Inc.
70 Watts Avenue
Charlottetown
C1E 2B9
Prince Edward Island
CANADA