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Health product recall

Indicator One-Step Home Pregnancy Test (Midstream Format) and LH Ovulation Test (Strip Format) (2013-08-09)

Starting date:
August 9, 2013
Posting date:
April 30, 2014
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-39209

Recalled products

  1. Indicator One-Step Home Pregnancy Test (Midstream Format)
  2. LH Ovulation Test (Strip Format)

Reason

Product may not conform to specifications including shelf-life. Device may produce inaccurate results.

Affected products

A. Indicator One-Step Home Pregnancy Test (Midstream Format)

Lot or serial number
  • 1110M11
Model or catalog number
  • 100-16
Companies
Manufacturer
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA

B. LH Ovulation Test (Strip Format)

Lot or serial number
  • 3-L11231
  • 5-L07281
  • 5-L09291
Model or catalog number
  • 200-1
Companies
Manufacturer
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA