Privapath Universal Sexual Health Testing Kit Recall: Risk of Blood Exposure

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Contact the company & request your remedy

Recalling firmPrivapath Diagnostics LtdUnit A10 Block A, Calmount Park; Calmount Avenue · Dublin 12, N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Privap: Universal Sexual Health Testing Kits with lot numbers 1189, 1094, 144, 226, and 82 are recalled. Damaged tubes could lead to blood exposure or incorrect test results.

Why it’s dangerous

Damaged tubes in the testing kit could cause blood to mix with the additive in an incorrect ratio, leading to inaccurate test results or potential blood exposure.

Who’s affected

People who purchased or use the Universal Sexual Health Testing Kit with the listed lot numbers. Those who have the kit may face inaccurate results or blood exposure risks.

How to tell if you have this one

Check the lot numbers on the kit: 1189, 1094, 144, 226, or 82. The product is sold by Privapath Diagnostics Ltd.

Brand
Privapath
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify if your kit has lot numbers 1189, 1094, 144, 226, or 82.

✎ GovInfoNow

Questions people ask

What lot numbers are affected?

Lot numbers 1189, 1094, 144, 226, and 82.

Why is this kit being recalled?

Damaged tubes could cause blood exposure or inaccurate test results due to an improper blood-to-additive ratio.

What should I do if I have the affected kit?

The recall record does not specify a remedy, so check with Privapath Diagnostics Ltd for guidance.

Take action

Contact Privapath

We’ve drafted a message you can send Privapath to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0350-2020 — Privapath Privapath

Hello,

I own a Privapath that is covered by recall Z-0350-2020 from Privapath.

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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Where this comes from

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.

Official source: FDA Recall #Z-0350-2020 (July 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0350-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Privapath Diagnostics Ltd recalls Universal Sexual Health Testing Kit

Lower-risk recall