Health product recall

HPFast (2019-03-05)

Starting date:
March 5, 2019
Posting date:
April 29, 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-69752

Last updated: 2019-04-30

Affected Products

HPFast

Reason

GI Supply is voluntarily recalling a specific lot of Positive Control Urease/Glycerol Solutions that accompany HPOne and HPFast products. Based on a single, recent complaint investigation, it was found that one lot of the Positive Control solution has the potential of providing unclear or inaccurate results.

Affected products

HPFast

Lot or serial number
  • 183371
  • 183521
  • 183601
  • 190021
  • 190071
  • 190171
  • 190211
Model or catalog number
  • GHP-U
  • GIS-64M
Companies
Manufacturer
GI Supply
5069 Ritter Rd Suite 104
Mechanicsburg
17055
Pennsylvania
UNITED STATES