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.
Reason for Recall / Hazard
Due to product exhibiting potential to generate either invalid or false negative results.
Product Description & Identification
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Affected Products
Brand 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 |
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Overview
- Recalling FirmHologic, Inc.
- StatusOngoing
- Risk LevelClass 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/recalls/brand-name-aptima-hpv-assay-product-name-aptima-hpv-assay-model-catalo/FDA-Z-1586-2026
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