Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2289-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

Product Classification:

Class II

Date Initiated: July 10, 2019

Date Posted: August 28, 2019

Recall Number: Z-2289-2019

Event ID: 83349

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.

Status: Terminated

Product Quantity: 4780 (6266 additional as of 1/13/20)

Code Information:

kit lots 0259 and above; UDI: 00630414985732

Distribution Pattern:

Global distribution. US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated