FDAClass IINovember 20, 2019

Universal Sexual Health Testing Kit recall

Universal Sexual Health Testing Kit

Why was Universal Sexual Health Testing Kit recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot numbers: 1189 1094 144 226 82

Product
Universal Sexual Health Testing Kit
Recalling firm
Privapath Diagnostics Ltd
Quantity
N/A
Distribution
Nationwide
Recall date
November 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls