Macherey Nagel Gmbh & Co. Kg
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Macherey Nagel Gmbh & Co. Kg and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-05-22FDA-DeviceClass IIReagent 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.
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.
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