# FDA recall Z-1834-2024

> **Macherey Nagel Gmbh & Co. Kg** · Class II · device recall initiated 2024-04-04.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1834-2024
- **Recalling firm:** Macherey Nagel Gmbh & Co. Kg
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-04
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Duren, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2024

## Citation

> AI Analytics. FDA recall Z-1834-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1834-2024. Source: US FDA. Licensed CC0.

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