This page has been archived on the Web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.
ZYMUTEST HIA IGGAM (2017-11-09)
- Starting date:
- November 9, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65274
Affected products
ZYMUTEST HIA IGGAM
Reason
We received one US customer complaint related to negative control out of range for ZYMUTEST HIA IgGAM, RK040D, lot F1700415. Subsequent investigation of this lot produced 2 false positive results. ZYMUTEST HIA MonoStrip IgGAM, RK041D, lot 1700416 is also impacted as some components are common to both lots. Use of these lots may produce false positive results.
Affected products
ZYMUTEST HIA IGGAM
Lot or serial number
F1700415
F1700416
Model or catalog number
RK040D
RK041D
Companies
- Manufacturer
-
HYPHEN BIOMED
155 RUE D' ERAGNY, NEUVILLE SUR OISE
95000
FRANCE