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.
This recall is currently active, issued September 27, 2024. It was issued by Healgen Scientific Llc.
- Company
- Healgen Scientific Llc
- Recall Initiated
- August 22, 2024
- Posted
- September 27, 2024
- Recall Number
- Z-3303-2024
- Quantity
- 1,636,994 Tests
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
Distribution
U.S. Nationwide distribution in the states of CA, GA and TX.
Lot / Code Info
Product Item Code: Urinox-P30 UDI-DI code: 196852593453 Lot Number: N2310003 N2310012 N2305013 N2308006 N2209013 N2302034 N2303002 Product Item Code: URS-11T UDI-DI code: 00816490024347 Lot Number: N2311002 N2306012 Product Item Code: Urinox10-30 UDI-DI code: 099654011043 Lot Numbers: N2311004 N2305015 N2305025 N2308011 N2309011 N2302027 N2302032 Product Item Code: URS-10T UDI-DI code: 00816490024323 Lot Numbers: N2311007 N2306001 N2306013 N2308004 N2309002 N2211004 Product Item Code: Urinox10-20 UDI-DI code: 707486987534 Lot Numbers: N2305014 N2305024 N2308010 N2309010 N2302031 Product Item Code: Urinox-10-60 UDI-DI code: 707486987053 Lot Numbers: N2305026 N2306006 N2308012 N2302028 N2302033 Product Item Code: URS-4T UDI-DI code: 00816490024330 Lot Number: N2306014
Root Cause
Nonconforming Material/Component
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.