Recall Z-3303-2024 ยท JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Healgen Scientific Llc
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
| Date | Sep 27, 2024 (initiated Aug 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 o |
| Quantity | 1,636,994 Tests |
| Distribution | U.S. Nationwide distribution in the states of CA, GA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL Healgen Scientific,, LLC, Apr 17, 2012 |