Z-1834-2024 Class II Ongoing
FDA device recall Z-1834-2024 was initiated by Macherey Nagel Gmbh & Co. Kg on Apr 4, 2024 and is designated Class II. 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)… The recall status is ongoing. Affected quantity: 5,200 packages.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Apr 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,200 packages
Product Description
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.
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 Pattern
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
Code Information
Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1834-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026