Reagent Test Strips for Blood — Class II medical device recall Z-1834-2024
Ongoing recall by Macherey Nagel Gmbh & Co. Kg, reported 2024-05-22, distributed nationwide. The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the te
| Recall number | Z-1834-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macherey Nagel Gmbh & Co. Kg, Duren, N/A, Germany |
| Recall initiated | 2024-04-04 |
| Classified | 2024-05-16 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 5,200 packages |
| UPC / GTIN / UDI-DI | 00304040001479 |
| Lot numbers | 65402 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1834-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.