FDA Medical Device Recalls (openFDA)
Privapath Diagnostics Ltd: Universal Sexual Health Testing Kit
- Recall number
- Z-0350-2020
- Recalling firm
- Privapath Diagnostics Ltd
- Product
- Universal Sexual Health Testing Kit
- Status
- Terminated
- Initiated
- 2019-07-01
- Posted
- not on file
- Terminated
- 2020-11-23
- Reason
- A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.
- Root cause
- Nonconforming Material/Component
- Action
- PrivaPath Diagnostics telephoned and or issued emails to all customers and stated the following: PrivaPath Diagnostics has not received any reports from any customers or laboratory partners regarding this issue and the telephone call/email is just a precautionary action. However, PrivaPath Diagnostics PrivaPath Diagnostics is working closely with the supplier to ensure that this issue does not recur. If contact has been unsuccessful the customer will be sent a second email. This action ensures that in the case of a potential erroneous result it is followed up upon either through a replacement kit with LetsGetChecked with an unaffected lot number or with another healthcare provider.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- lot numbers: 1189 1094 144 226 82
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3015209536
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28