Z-0350-2020 Class II Terminated
FDA device recall Z-0350-2020 was initiated by Privapath Diagnostics Ltd on July 1, 2019 and is designated Class II. 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. The recall status is terminated (terminated November 23, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- November 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Universal Sexual Health Testing Kit
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.
Distribution Pattern
Nationwide
Code Information
lot numbers: 1189 1094 144 226 82