Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2290-2019)

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 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

Product Classification:

Class II

Date Initiated: July 10, 2019

Date Posted: August 28, 2019

Recall Number: Z-2290-2019

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: 6633 (4753 additional as of 1/13/20)

Code Information:

US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989

Distribution Pattern:

Global distribution. US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated