Official recall record
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocyt
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-04
- Country of alert
- Germany
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00304040001479
- Brand on record
- Macherey Nagel Gmbh & Co. Kg
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.