Hologic recalls Aptima HPV Assay Kit (model 303585) due to potential for false negatives. Affected kits may give incorrect results, leading to missed diagnoses. Contact Hologic for details.
Due to product exhibiting potential to generate either invalid or false negative results.
Hologic recalls the Aptima HPV Assay Kit (model 303585) because it can produce false negative results, meaning it might miss HPV infections. This could lead to incorrect health decisions if used for testing.
The kit can generate false negative results, meaning it might show no HPV infection when one is present. This could lead to missed diagnoses and incorrect health decisions. The risk is not immediate but depends on the test's use in clinical settings.
Healthcare providers and labs using the Aptima HPV Assay Kit (model 303585) are affected. Those testing for HPV infections may be at risk of incorrect results.
Check for the model number 303585 on the kit. The kit includes a refrigerated box (PN 302883) and a room temperature box (PN 302885). UDI numbers 15420045500051 and 15420045500068 identify the affected kits.
Verify the model number 303585 and UDI numbers 15420045500051 or 15420045500068 on the kit.
The model number is 303585.
UDI numbers 15420045500051 and 15420045500068 are affected.
The recall does not specify a stop-use instruction, so you may continue using it if you check the model and UDI numbers.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1586-2026 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1586-2026 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
