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:

Affected Products

  1. Spartan Cube Covid-19 System Platform
  2. Spartan Cube Covid-19 System - Computer
  3. Spartan Cube Covid-19 System - Cube
  4. Spartan Cube Covid-19 Test Materials
  5. Spartan Cube Covid-19 System - Test Kit(s)
  6. Spartan Cube Covid-19 System - Test Box
  7. 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