Medical Device Recall: 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.
Macherey Nagel Gmbh & Co. Kg · April 4, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
States Affected
NATIONWIDE
Quantity Affected
5,200 packages
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1834-2024
Status: ongoing
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