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Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874
Recalled August 28, 2019 · FDA recall Z-2290-2019 · 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
6633 (4753 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 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →