Reagent Test Strips for Urinalysis Recalled Due to Missing Leukocytes Pad
Macherey Nagel urinalysis test strips are recalled due to a missing leukocytes test pad on some packages, potentially resulting in false negative results for urinary tract infections and renal inflammation. Affected lot: 65402.
What this means for you
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: This is a Class II medical device recall where a critical test parameter (leukocytes) is missing from some diagnostic strips, which could lead to false negative results and missed diagnoses of urinary tract infections or renal inflammation. While no illnesses or injuries have been reported, the potential for diagnostic failure represents a risk-of-harm product recall.
Plain-English summary
The FDA is recalling Macherey Nagel's Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity, and Leucocytes (Urispec 11-Way) due to a manufacturing defect.
One of the test pads, specifically the leukocytes parameter pad, was missing on some test strips in affected lots. Leukocytes is a non-specific marker for urinary tract infections and an indicator for inflammatory renal processes. Missing this test pad could result in false negative readings, potentially causing these conditions to go undiagnosed.
The recall affects product #102-2285, LOT 65402, which was distributed nationwide in Colorado, Florida, Indiana, Nevada, and Texas. Approximately 5,200 packages were distributed.
Consumers and healthcare providers should stop using affected test strips from LOT 65402 and contact the manufacturer or distributor for replacement strips.
The recalled product
- Product
- Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
- Manufacturer
- Macherey Nagel Gmbh & Co. Kg
- Hazard
- false-negative
- diagnostic-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product #102-2285
- UDI/DI: 00304040001479
- LOT 65402.
Distribution
Distributed nationwide across the United States.
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