Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 9, 2024
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Healgen Scientific Llc recalled Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned o… - a moderate-severity action.
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned o… was recalled by Healgen Scientific Llc in October 9, 2024. Reason: The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip product…. Check the official notice for the remedy. Verify recall #Z-3303-2024 with the FDA Devices before acting.
The recall
Healgen Scientific Llc issued this moderate-severity FDA Devices recall-The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip product….
- Moderate
- severity level
- Class II
- classification
- October 9, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3303-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3303-2024) was formally reported on October 9, 2024, with the manufacturer initiating the action on August 22, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Healgen Scientific Llc is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 1,636,994 Tests.
The documented reason for this recall is: The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by … Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of CA, GA and 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
1,636,994 Tests
Related Recalls
6
3 from same agency
Product description
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
Reason for recall
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3303-2024 |
| Date reported | October 9, 2024 |
| Date initiated | August 22, 2024 |
| Recalling firm | Healgen Scientific Llc |
| Firm location | Houston, TX |
| Affected scope | 1,636,994 Tests |
| Distribution | U.S. Nationwide distribution in the states of CA, GA and 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-3303-2024) 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? ▼
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.. Recalled by Healgen Scientific Llc. Units affected: 1,636,994 Tests.
Why was this product recalled? ▼
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3303-2024.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of CA, GA and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3303-2024) 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 October 9, 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.