Urinalysis reagent strips recalled for reduced protein detection sensitivity
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries have been reported. This is a Class II recall of a diagnostic medical device with reduced sensitivity and risk of false negative results—a risk-of-harm situation without confirmed injury, which per the rubric corresponds to High severity.
Plain-English summary
Healgen Scientific LLC is recalling Healgen Series Reagent Strips for Urinalysis distributed in California, Georgia, and Texas. The recall covers 1,636,994 test units across multiple product item codes and lot numbers. These test strips are used in urinalysis testing to detect glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, ascorbic acid, and leukocytes.
The strips have been found to exhibit reduced sensitivity in detecting urinary protein, potentially producing false negative results. The defect is caused by uneven color fading on the protein test pad, which interferes with visual or instrumental reading compared to the manufacturer's color chart. This could lead to a delay in identifying potential kidney disease and other conditions associated with elevated protein levels in urine, as well as a delay in patient evaluation and treatment.
Detailed information on affected lot numbers and product codes is available from the FDA. Healthcare providers and laboratory personnel should consult the recall notice for identification of affected inventory in their facilities.
The recalled product
- Product
- Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color…
- Manufacturer
- Healgen Scientific Llc
- Affected units
- 1,636,994
Distribution
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