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Recall Observatory FDA recall evidence

Device product

IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

Z-2289-2019

July 10, 2019

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 83349
Status
Terminated
Classification
Class II
Quantity
4780 (6266 additional as of 1/13/20)
Official record key
device-enforcement:Z-2289-2019

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: kit lots 0259 and above; UDI: 00630414985732

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.