Healgen Scientific recalls urine test strips with potential false negative protein results, risking delayed kidney disease detection. Affected lots include Urinox-P30, URS-11T, and other models from specific production dates.
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip 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.
Healgen Scientific is recalling urine test strips that may show false negative results for protein detection. This could delay identifying kidney diseases or other conditions requiring treatment, as protein in urine can indicate serious health issues.
The test strips may show uneven color fading on the protein pad, leading to false negative results. This means protein in urine might not be detected, potentially delaying treatment for kidney diseases or other conditions.
People who use Healgen urine test strips for home urinalysis are affected. Those with kidney conditions or elevated protein levels in urine are at higher risk of delayed diagnosis.
Check for product codes: Urinox-P30, URS-11T, Urinox10-30, URS-10T, Urinox10-20, Urinox-10-60, or URS-4T. Look for specific lot numbers listed in the recall notice.
Identify your test strip model and lot number by checking the product code and lot numbers listed in the recall notice.
Healgen Scientific determined their urine test strips may show reduced sensitivity for protein detection, leading to potential false negative results.
False negative results could delay identifying kidney diseases or other conditions associated with elevated protein levels in urine, requiring prompt medical evaluation.
Check for product codes like Urinox-P30, URS-11T, or other models listed with specific lot numbers in the recall notice.
We’ve drafted a message you can send Healgen to request your refund or repair — edit it as you like.
Subject: Recall Z-3303-2024 — Healgen Healgen Hello, I own a Healgen that is covered by recall Z-3303-2024 from Healgen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
