Health product recall

Multi-Drug Screen Test ECO II Cup (2018-08-16)

Starting date:
August 16, 2018
Posting date:
August 31, 2018
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-67634

Affected products

Multi-Drug Screen Test ECO II Cup

Reason

Name of the product on outer case and inner box label (urine drug of abuse test) is different from name on the medical device licence (Multi-Drug Screen Test ECO II Cup). Outer case, inner box are missing manufacturer name and address as required by mdr. Defectiveness was discovered during annual renewal of the device licence# 94297 on August 8, 2018.

Affected products

Multi-Drug Screen Test ECO II Cup

Lot or serial number

All lots.

Model or catalog number
  • 100-7037-200
  • 100-7037-300
Companies
Manufacturer

W.H.P.M., INC.

5358 N Irwindale Avenue, Unit A

Irwindale

91706

California

UNITED STATES