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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Sexual Health Testing Kit

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 Class 2 Device Recall Universal Sexual Health Testing Kitsee related information
Date Initiated by FirmJuly 01, 2019
Create DateNovember 08, 2019
Recall Status1 Terminated 3 on November 23, 2020
Recall NumberZ-0350-2020
Recall Event ID 83709
Product Classification unknown device name - Product Code N/A
ProductUniversal Sexual Health Testing Kit
Code Information lot numbers: 1189  1094 144 226 82
FEI Number 3015209536
Recalling Firm/
Manufacturer		 Privapath Diagnostics Ltd
Unit A10 Block A
Calmount Park; Calmount Avenue
Dublin 12 Ireland
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPrivaPath 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.
DistributionNationwide
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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