Z-2290-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 10, 2019
- Termination Date
- May 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6633 (4753 additional as of 1/13/20)
Product Description
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Reason for Recall
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
Distribution Pattern
Global distribution. US Nationwide.
Code Information
US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989