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Macherey Nagel Gmbh & Co. Kg recalls Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific
Recalled May 22, 2024 · FDA recall Z-1834-2024 · Macherey Nagel Gmbh & Co. Kg
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. · FDA Class II
Units
5,200 packages
Sold at
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
Description
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.
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(s)
Macherey Nagel Gmbh & Co. Kg
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →