URGENT MEDICAL DEVICE RECALL

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August 22, 2024

Last Updated on Sep 4, 2024.‍

Important Recall Notice for Urinox-10 and Urine Protein Test Strips

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At Diagnox Health, we are committed to upholding the highest standards of quality and safety for our products. As part of this commitment, we are notifying our valued customers about an important recall initiated by our supplier, Healgen Scientific LLC.

Recall Details:

Healgen Scientific, the manufacturer of our Urinox-branded reagent strips, has identified a manufacturing defect in certain LOTs of Urinox-10 and Urine Protein Test Strips. This defect has led to reduced sensitivity and potential false negative results for detecting trace or mild proteinuria.

Affected Products:

1. Urinox-10 Urinary Reagent Test Strips
2. Urine Protein Test Strips

Please refer to the full list of affected LOT numbers provided by Healgen Scientific in their official recall letter.

Specifics of Defect:

The defect relates to the raw material (Tetrabromophenol blue) used in the protein test pad, provided by a specific supplier. This material may cause reduced sensitivity or false negatives for trace and low levels of proteinuria. However, results at higher levels of protein were not impacted.

The manufacturer's batch records indicate that this raw material was used in 33 lots of urinalysis strips, some of which were supplied to Diagnox. Although not all LOTs were equally impacted and some passed QC, as a precaution, all lots containing this raw material are being recalled.

‍Affected Product LOTs

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Actions for Sub-Distributors:

1. Carefully read the recall letter.
2. Immediately examine your inventory and quarantine products subject to recall.
3. Stop the sale and usage of the affected lots.
4. Recall the affected products from the market.
5. Ship recalled products to Diagnox’s warehouse within one month of this notice.
6. Submit the inventory report of the affected lots to Diagnox.
7. Diagnox will provide free replacements once the defective products are returned.
8. Inform end-users or sellers of this recall and the necessary actions.

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Actions for Consumers:

1. Check your product’s lot number, printed on the bottom flap of the packaging, and compare it to the affected lots.
2. If your product's lot number is not listed, you can continue using the product safely.
3. If your product’s lot number is included in the recall, stop using the product immediately.
4. Use the form widget below to request a replacement unit.

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Health Risks and Adverse Events

This is a voluntary Class II recall, meaning the risk of serious adverse health consequences is low. Key considerations include:

• Hazard: The defect may cause reduced sensitivity or false negative results for detecting trace or mild proteinuria (limited to two levels).
• Harm: There is a potential delay in diagnosing or managing conditions associated with proteinuria, with the worst-case severity categorized as “Serious.”
• Probability: Given that diagnoses are typically made in conjunction with clinical examination, medical history, and other tests, the probability of adverse effects is classified as “Remote” to “Improbable.”
• Overall Risk to Health: The overall risk is considered LOW.

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If any adverse events occur, distributors and/or sub-distributors must report them to the FDA via MDR.

An adverse event refers to irreversible injuries such as death, disability, permanent damage, or significant medical issues requiring intervention.

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It is important to note that an incorrect result from a medical device is not considered an adverse event unless it leads to irreversible and serious harm.

Healthcare professionals, consumers, and patients who encounter issues with medical devices can report them to the FDA through MedWatch.

Corrective Action: Steps Taken to Rectify the Issue

The manufacturer has taken the following steps to correct the issue and prevent it from happening in the future:

• The purchase of Tetrabromophenol blue from the affected supplier has been suspended.
• A new supplier for the raw material has been identified, validated, and incorporated into production.
• Additional enhanced stability testing protocols have been implemented to ensure quality and reliability.

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Specific Testing and Monitoring Measures:

• In-Process Raw Material Testing: New raw materials from the new supplier have undergone accelerated stability studies.
• Finished Products: Products made with the new raw materials have demonstrated stability in accelerated stability studies.
• Ongoing Monitoring: Continued monitoring has been put in place to ensure that the products maintain full stability and shelf-life.

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Documents:

Please download and read the following carefully.

1. Recall Notice
2. Table of Affected LOTs
3. Editable for Customers: Field Correction Effectiveness Check

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Further Information:

‍This recall is being conducted by Healgen Scientific with the full knowledge of the U.S. Food and Drug Administration (FDA). We apologize for any inconvenience this may cause and appreciate your understanding as we work to resolve this issue swiftly.

If you have any questions or concerns, please contact Healgen Scientific at quality@healgen.com or reach out to Diagnox Health's customer service team at contact@diagnoxhealth.com.

Thank you for your prompt attention to this matter and for your continued trust in Diagnox Health.

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