Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
USBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Recalling Firm: Hologic, Inc.
Motif du rappel / Danger
TranslatedDue to product exhibiting potential to generate either invalid or false negative results.
Description du produit & Identification
TranslatedBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Produits concernés
TranslatedBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 98441 |
| Address 1 | 10210 Genetic Center Dr |
| Address 2 | N/A |
| Code info | Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box: UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068 |
| Postal code | 92121-4362 |
| Report date | 20260325 |
| Product type | Devices |
| Product quantity | 306 |
| Reason for recall | Due to product exhibiting potential to generate either invalid or false negative results. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Initial firm notification | Letter |
| Center classification date | 20260319 |
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 Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima...?
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.
Vérifiez les autres produits de votre foyer
Outils gratuitsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Aperçu
- Entreprise responsableHologic, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionU.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
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🚨 SAFETY ALERT: Hologic, Inc. - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No Check if your household is affected: https://therecallfile.com/fr/recalls/brand-name-aptima-hpv-assay-product-name-aptima-hpv-assay-model-catalo/FDA-Z-1586-2026
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