Urinalysis Strips
Last updated
Summary
Product
Urinalysis Strips
Issue
Medical devices - Performance
What to do
Manufacturer will contact users to stop using and return affected units.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Urinalysis Strips |
N2311002 |
URS-11T |
Issue
The urinalysis strips products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
Recall start date: October 10, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Healgen Scientific Limited Liability Company |
| 3818 Fuqua St, Houston, Texas, United States, 77047 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76496
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