Class II — Macherey Nagel Gmbh & Co. Kg
| Recalling firm | MACHEREY-NAGEL GMBH & CO. KG. |
|---|---|
| Registered facility | MACHEREY-NAGEL GMBH & CO., KG. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 5,200 packages |
| Distribution | US Nationwide distribution in the states of CO, FL, IN, NV, TX. |
| Initiated | 2024-04-04 |
| Classified | 2024-05-16 |
| Recall number | Z-1834-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Macherey Nagel Gmbh & Co. Kg (Z-1834-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94454/
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