Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Reagent Test Strips for Blood Recalled by Macherey Nagel Gmbh & Co. Kg Due to The reason for the recall is one of...

Date: April 4, 2024
Company: Macherey Nagel Gmbh & Co. Kg
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Macherey Nagel Gmbh & Co. Kg directly.

Affected Products

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.

Quantity: 5,200 packages

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Macherey Nagel Gmbh & Co. Kg

Macherey Nagel Gmbh & Co. Kg has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report