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Recall Observatory FDA recall evidence

Device product

Universal Sexual Health Testing Kit

Z-0350-2020

July 01, 2019

Class II

Product summary

Firm
Privapath Diagnostics Ltd
Event
Event 83709
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0350-2020

Official wording

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.

Code information: lot numbers: 1189 1094 144 226 82

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.