ZYMUTEST HIA MonoStrip IgG & IgGAM(2019-07-23)
- Starting date:
- July 23, 2019
- Posting date:
- August 9, 2019
- 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-70649
Last updated: 2019-08-09
Affected Products
A. ZYMUTEST HIA MonoStrip IgG
B. ZYMUTEST HIA MonoStrip IgGAM
Reason
The manufacturer has issued a recall for two in vitro diagnostic devices which involve residual crystallization and recurrent negative controls out of range.
Affected products
A. ZYMUTEST HIA MonoStrip IgG
Lot or serial number
F17010884
F1900611
Model or catalog number
RK041A
Companies
- Manufacturer
-
HYPHEN BIOMED
155 RUE D'ERAGNY
NEUVILLE SUR OISE
95000
FRANCE
B. ZYMUTEST HIA MonoStrip IgGAM
Lot or serial number
F1701571
Model or catalog number
RK041D
Companies
- Manufacturer
-
HYPHEN BIOMED
155 RUE D'ERAGNY
NEUVILLE SUR OISE
95000
FRANCE