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Terminated

Universal Sexual Health Testing Kit

FDA Recall Z-0350-2020 · Posted None

Recall StatusTerminated
Product CodeN/A
Date Initiated2019-07-01
Date Terminated2020-11-23

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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