Z-2289-2019 Class II Terminated
FDA device recall Z-2289-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on July 10, 2019 and is designated Class II. 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 supplementati… The recall status is terminated (terminated May 28, 2024). Affected quantity: 4780 (6266 additional as of 1/13/20).
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
- 4780 (6266 additional as of 1/13/20)
Product Description
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
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
kit lots 0259 and above; UDI: 00630414985732