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Recall Observatory FDA recall evidence

Device product

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

Z-2290-2019

July 10, 2019

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 83349
Status
Terminated
Classification
Class II
Quantity
6633 (4753 additional as of 1/13/20)
Official record key
device-enforcement:Z-2290-2019

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.