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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1834-2024

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.

Publicado el 22 de mayo de 2024 · Inicio del retiro: 4 de abril de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Macherey Nagel Gmbh & Co. Kg
Distribuidor
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
Lote
Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
Clasificación de riesgo
Class II
Área (FDA)
device
País
Germany

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