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