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Various IND Diagnostic Inc. Test Kits (2014-04-28)
- Starting date:
- April 28, 2014
- Posting date:
- June 5, 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-39891
Recalled Products
a) HCG Pregnancy Test (Cassette Format)
b) HCG Pregnancy Test (Strip Format)
c) HCG Pregnancy Test (Midstream Format)
d) HCG Pregnancy Combo Test (Cassette Format)
e) HCG Pregnancy Combo Test (Strip Format)
f) LH Ovulation Test (Cassette Format)
g) LH Ovulation Test (Strip Format)
h) LH Ovulation Test (Midstream Format)
i) Fecal Occult Blood Test (Cassette Format)
j) One-Step Cocaine Test (Strip Format)
k) One-Step Amphetamine Test (Strip Format)
l) One-Step Methamphetamine Test (Strip Format)
m) One-Step Marijuana Test (Strip Format)
n) Urinalysis Reagent Strip 10P
o) Urinalysis Reagent Strip 11P
p) Alcohol Saliva Test
q) FSH Menopause Test (Cassette Format)
Reason
To ensure that all IND Diagnostic Canadian customers are aware that IND medical device licences were suspended on February 8, 2013 and therefore sale of the affected devices is prohibited in Canada.
Affected products
a) HCG Pregnancy Test (Cassette Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
b) HCG Pregnancy Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
c) HCG Pregnancy Test (Midstream Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
d) HCG Pregnancy Combo Test (Cassette Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
e) HCG Pregnancy Combo Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
f) LH Ovulation Test (Cassette Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
g) LH Ovulation Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
h) LH Ovulation Test (Midstream Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
i) Fecal Occult Blood Test (Cassette Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
j) One-Step Cocaine Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
k) One-Step Amphetamine Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
l) One-Step Methamphetamine Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
m) One-Step Marijuana Test (Strip Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
n) Urinalysis Reagent Strip 10P
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
o) Urinalysis Reagent Strip 11P
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
p) Alcohol Saliva Test
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA
q) FSH Menopause Test (Cassette Format)
Lot or serial number
Various serial number contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
IND Diagnostics Inc.,
1629 Fosters Way
Delta
V3M 6S7
British Columbia
CANADA