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