FDA-Device2019-08-28Class II
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Global distribution. US Nationwide.
Affected count
6633 (4753 additional as of 1/13/20)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2019Don't want to check this manually?
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