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.
Published May 22, 2024 · Recall initiated: April 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative . The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Macherey Nagel Gmbh & Co. Kg
- Distributor
- US Nationwide distribution in the states of CO, FL, IN, NV, TX.
- Lot
- Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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