Macherey Nagel Gmbh & Co. Kg recalls Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific…

Recall date

April 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1834-2024

FDA classification

Class II

Brand / firm

Macherey Nagel Gmbh & Co. Kg

Sold / distributed

US Nationwide distribution in the states of CO, FL, IN, NV, TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.