Public recall detail

Urinalysis Strips

2024-11-13

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Recall Safety notice
Quick summary

Quick summary: Urinalysis Strips. Date: 2024-11-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Urinalysis Strips. Date: 2024-11-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHealgen Scientific Limited Liability Company
ProductUrinalysis Strips
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76496

Affected products

ProductUrinalysis Strips
LotN2311002
ModelURS-11T
Serial numberN2311002
DescriptionUrinalysis Strips

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

What you should do

  • Manufacturer will contact users to stop using and return affected units.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesHealgen Scientific Limited Liability Company 3818 Fuqua St, Houston, Texas, United States, 77047
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76496
Background{}
CompaniesHealgen Scientific Limited Liability Company 3818 Fuqua St, Houston, Texas, United States, 77047
AudiencesHealthcare
Source updated2024-11-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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