Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 22, 2024
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.
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 S…
Macherey Nagel Gmbh & Co. Kg recalled Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorb… - a moderate-severity action.
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorb… was recalled by Macherey Nagel Gmbh & Co. Kg in May 22, 2024. Reason: The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the t…. Check the official notice for the remedy. Verify recall #Z-1834-2024 with the FDA Devices before acting.
The recall
Macherey Nagel Gmbh & Co. Kg issued this moderate-severity FDA Devices recall-The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the t….
- Moderate
- severity level
- Class II
- classification
- May 22, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1834-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1834-2024) was formally reported on May 22, 2024, with the manufacturer initiating the action on April 4, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Macherey Nagel Gmbh & Co. Kg is listed as the recalling firm, operating out of Duren, N/A. Federal records list the affected scope as 5,200 packages.
The documented reason for this recall is: 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. Th… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CO, FL, IN, NV, TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,200 packages
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1834-2024 |
| Date reported | May 22, 2024 |
| Date initiated | April 4, 2024 |
| Recalling firm | Macherey Nagel Gmbh & Co. Kg |
| Firm location | Duren, N/A |
| Affected scope | 5,200 packages |
| Distribution | US Nationwide distribution in the states of CO, FL, IN, NV, TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1834-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macherey Nagel Gmbh & Co. Kg. Units affected: 5,200 packages.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1834-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of CO, FL, IN, NV, TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1834-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 22, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.