ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
USProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Recalling Firm: Bioporto Diagnostics A/S
Motivo del Retiro / Peligro
TranslatedThe use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Descripción del Producto e Identificación
TranslatedProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Additional Source Details
| Field | Value |
|---|---|
| City | Hellerup |
| Event id | 99266 |
| Address 1 | Tuborg Havnevej 15, St |
| Code info | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 400 units |
| Reason for recall | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Initial firm notification | |
| Center classification date | 20260812 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableBioporto Diagnostics A/S
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.
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🚨 SAFETY ALERT: Bioporto Diagnostics A/S - ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. Check if your household is affected: https://therecallfile.com/es/recalls/pronephro-aki-ngal-reagent-kit-100-tests-ivd-acute-kidney-injury-test/FDA-Z-2937-2026
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