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Healgen Scientific Llc: Healgen Series Reagent strips for Urinalysis are

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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.. Recalled by Healgen Scientific Llc. Distribution: U.S. Nationwide distribution in the states of CA, GA and TX.. Classification (Class II — potential health risk). Affected lots/dates: Produ

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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