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Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Recalled August 28, 2019 · FDA recall Z-2289-2019 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
4780 (6266 additional as of 1/13/20)
Sold at
Global distribution. US Nationwide.
Description
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.
Product
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →