CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Reagent Test Strips for Blood, Urobilinogen, Bilirubin recalled
Macherey Nagel Gmbh & Co. Kg is recalling Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, distributed nationwide in the US. The recall was initiated on 4 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1834-2024
- FDA event ID
- 94454
- Recalling firm
- Macherey Nagel Gmbh & Co. Kg, Duren, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Apr 2024
- FDA classified
- 16 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 4 Apr 2024 | Recall initiated by company | |
| 16 May 2024 | Classified by FDA | +42 days |
| 22 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
Questions about this recall
Is Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones recalled?
Yes. Macherey Nagel Gmbh & Co. Kg recalled Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones on 4 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1834-2024.
Why was it 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.
Which lots are affected?
Product #102-2285, UDI/DI: 00304040001479, LOT 65402.
Where was it sold?
US Nationwide distribution in the states of CO, FL, IN, NV, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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