Health product recall

CRYOcheck Lupus Positive Control (2019-01-08)

Starting date:
January 8, 2019
Posting date:
January 25, 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-68926

Affected Products

CRYOcheck Lupus Positive Control

Reason

An error was identified in the Assay Certificate for our product CRYOcheck Lupus Positive Control, cat# CCLP-05 and CCLP-10, lot# 6254. All information that is present on the Assay Certificate is correct, however, we inadvertently omitted the Normal Range values

Affected products

CRYOcheck Lupus Positive Control

Lot or serial number

Lot # 6254

Model or catalog number
  • CCLP-05
  • CCLP-10
Companies
Manufacturer

Precision BioLogic Inc.

140 Eileen Stubbs Avenue

Dartmouth, Nova Scotia

B3B 0A9

CANADA