Reported Oct 9, 2024 · Ongoing
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is…
Healgen Scientific LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Healgen Scientific Llc · 3818 Fuqua St · Houston, TX · 77047-4808
Is this the product you have?
- 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 chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
- Lot codes and dates
14 of 14 products
Products covered by this recall # Barcodes Product as published 1 196852593453Item Code: Urinox-P30 UDI-DI code: 196852593453 2 Lot Number: N2310003 N2310012 N2305013 N2308006 N2209013 N2302034 N2303002 Product 3 00816490024347Item Code: URS-11T UDI-DI code: 00816490024347 4 Lot Number: N2311002 N2306012 Product 5 099654011043Item Code: Urinox10-30 UDI-DI code: 099654011043 6 Lot Numbers: N2311004 N2305015 N2305025 N2308011 N2309011 N2302027 N2302032 Product 7 00816490024323Item Code: URS-10T UDI-DI code: 00816490024323 8 Lot Numbers: N2311007 N2306001 N2306013 N2308004 N2309002 N2211004 Product 9 707486987534Item Code: Urinox10-20 UDI-DI code: 707486987534 10 Lot Numbers: N2305014 N2305024 N2308010 N2309010 N2302031 Product 11 707486987053Item Code: Urinox-10-60 UDI-DI code: 707486987053 12 Lot Numbers: N2305026 N2306006 N2308012 N2302028 N2302033 Product 13 00816490024330Item Code: URS-4T UDI-DI code: 00816490024330 14 Lot Number: N2306014 - Amount recalled
- 1,636,994 Tests
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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