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Aptima®
Hologic, Inc. · Model KIT, BX 1(REF) HPV,100-T, AS, US IVD · UDI-DI 15420045500099
OYB
Prescription
0
510(k) clearances
42
Adverse events
1
Recalls
1
Facilities
Description
Aptima® HPV Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Hologic, Inc. | Due to product exhibiting potential to generate either invalid or false negative results. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.