Recall Z-1834-2024— Macherey Nagel Gmbh & Co. Kg

Name: FDA recall Z-1834-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-04

Class II · Ongoing

Class II FDA medical device recall by Macherey Nagel Gmbh & Co. Kg, initiated 2024-04-04. It names one FDA 510(k) clearance: K991927. 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: 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..

Recalling firm: Macherey Nagel Gmbh & Co. Kg
Classification: Class II
Status: Ongoing
Initiated: 2024-04-04
Firm location: Duren, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K991927 — MEDI-TEST COMBI 11Macherey-Nagel-Duren·cleared 1999-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.