Health product recall

Prolex Streptococcal Xtra Select Kit (2019-03-03)

Starting date:
March 3, 2019
Posting date:
April 5, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69486



Last updated: 2019-04-05

Affected Products

Prolex Streptococcal Xtra Select Kit

Reason

A non-conformance was identified on 2019/02/28 for an error on the kit outer label. Specifically, the name of the kit was omitted on the outer kit label.

Affected products

Prolex Streptococcal Xtra Select Kit

Lot or serial number
  • C16295
Model or catalog number
  • PL.1042
Companies
Manufacturer

Pro-Lab Diagnostics

20 Mural St, Unit 4

Richmond Hill

L4B 1K3

Ontario

CANADA