Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp
FDA device recall Z-3303-2024 · posted 2024-09-27 · Open, Classified
Recall details
- Recalling firm
- Healgen Scientific Llc
- 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.
- Action taken
- On 08/22/2024, the firm sent an initial "URGENT MEDICAL DEVICE (IVD) RECALL" Letter to customer to inform them that, Urinary Reagent Strip products have shown reduced sensitivity and potential false negative results for Protein test. An updated communication will be issued on 08/28/2024. Customers are instructed to: -Immediately examine their inventory and quarantine products subject to recall. -Stop the sale of this product immediately. -Stop or cease use of the products immediately. -Recall products in the market. -Ship recalled products to Healgen's warehouse in Houston within 1 month of this notice (OR dispose of the product and provide proof of destruction (records, pictures, etc.) to Healgen.) -Use Appendix II to record the inventory report of the affected lots and send it back to Healgen. -Inform the end-user or sub-distributor at once of this recall and the required actions. Customers may request the unaffected replacement products from their local Healgen sales at no charge. Contact QA of Healgen Scientific, LLC at quality@healgen.com or +1-713-733-8088 (Toll-Free) if you have any additional questions or concerns regarding this notification.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JIR
- Quantity affected
- 1,636,994 Tests
- Distribution
- U.S. Nationwide distribution in the states of CA, GA and TX.
- Date initiated
- 2024-08-22
- Date posted
- 2024-09-27
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL (K111999) | Healgen Scientific,, LLC | 2012-04-17 |