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FDAJuly 10, 2019device

IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414985732

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 — Recall Details · AllClear