Spartan Cube Covid-19 System (2020-05-05)
- Starting date:
- May 5, 2020
- Posting date:
- May 6, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72971
Last updated: 2020-06-15
Affected Products
- Spartan Cube Covid-19 System Platform
- Spartan Cube Covid-19 System - Computer
- Spartan Cube Covid-19 System - Cube
- Spartan Cube Covid-19 Test Materials
- Spartan Cube Covid-19 System - Test Kit(s)
- Spartan Cube Covid-19 System - Test Box
- Spartan Cube Covid-19 System - Swab Kit(s)
Reason
The Spartan Covid-19 System does not perform as claimed for its intended use in a clinical setting. There is a risk of false negative test results. The Spartan Covid-19 System is no longer intended for use in diagnosis and should be used for research use only.
Affected products
A. Spartan Cube Covid-19 System Platform
Lot or serial number
All lots.
Model or catalog number
- 51C01000
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
B. Spartan Cube Covid-19 System - Computer
Lot or serial number
All lots.
Model or catalog number
- 51C01001
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
C. Spartan Cube Covid-19 System - Cube
Lot or serial number
All lots.
Model or catalog number
- 51C01002
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
D. Spartan Cube Covid-19 Test Materials
Lot or serial number
All lots.
Model or catalog number
- 51C02013
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
E. Spartan Cube Covid-19 System - Test Kit(s)
Lot or serial number
All lots.
Model or catalog number
- 51C02011
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
F. Spartan Cube Covid-19 System - Test Box
Lot or serial number
All lots.
Model or catalog number
- 51C02011
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA
G. Spartan Cube Covid-19 System - Swab Kit(s)
Lot or serial number
All lots.
Model or catalog number
- 51C02002
Companies
- Manufacturer
-
Spartan Biosciences Inc.
2934 Baseline Rd., Suite 500
Ottawa
K2H 1B2
Ontario
CANADA