| Class 2 Device Recall Healgen Series Reagent Strips for Urinalysis | |
Date Initiated by Firm | August 22, 2024 |
Date Posted | September 27, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3303-2024 |
Recall Event ID |
95248 |
510(K)Number | K111999 |
Product Classification |
Indicator method, protein or albumin (urinary, non-quant.) - Product Code JIR
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Product | 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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Healgen Scientific Llc 3818 Fuqua St Houston TX 77047-4808
|
For Additional Information Contact | Marki Doucett 713-733-8088 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 1,636,994 Tests |
Distribution | U.S. Nationwide distribution in the states of CA, GA and TX. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JIR
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