Z-0350-2020Class II

Universal Sexual Health Testing Kit

Name: Z-0350-2020 Universal Sexual Health Testing Kit
Creator: Privapath Diagnostics Ltd
Published: 2019-07-01
License: https://open.fda.gov/license/

Privapath Diagnostics Ltd / initiated 2019-07-01 / Terminated / root cause: manufacturing process

FDA source

Privapath Diagnostics Ltd began a recall of Universal Sexual Health Testing Kit on 2019-07-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0350-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-01
Posted: 2019-11-08
Terminated: 2020-11-23
Recalling firm: Privapath Diagnostics Ltd
Product: Universal Sexual Health Testing Kit
Product code: N/A
Reason for recall: 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 tag: manufacturing process
FDA 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.
Distribution: Nationwide
Product codes and lots: lot numbers: 1189 1094 144 226 82

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0350-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0350-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-08

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)