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Health product recall

ZESTICA OVULATION TEST AND CONCEPTION PACK (2015-12-21)

Starting date:
December 21, 2015
Posting date:
January 14, 2016
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-56628

Affected Products

A. ZESTICA OVULATION TEST
B. ZESTICA CONCEPTION PACK

Reason

Unauthorised packaging and labelling activities were undertaken for Zestica Ovulation Test by the importer/distributor, Bescot Healthcare Canada Inc. The carton used in the packaging was from a previously expired lot with preprinted information (lot 20120915, expiry: 14/09/2014) on them. A stickered black-out label was placed on top of the preprinted information with new lot number and expiry date (lot 20140730 expiry 29/07/2016). The packaging and labelling activity for Zestica conception pack involved placing Zestica ovulation test kit and Zestica fertility lubricant (licence #87093), and IFU into a carton.

Affected products

A. ZESTICA OVULATION TEST

Lot or serial number

20140730

Model or catalog number

5060203270780

Companies
Manufacturer
Burdica Biomed Ltd.
33 Research Ave. North
Edinburg
EH14 4AP
UNITED KINGDOM

B. ZESTICA CONCEPTION PACK

Lot or serial number

20140730

Model or catalog number

50602032270797

Companies
Manufacturer
Burdica Biomed Ltd.
33 Research Ave. North
Edinburg
EH14 4AP
UNITED KINGDOM