Siemens Healthcare recalls IMMULITE 1000 Progesterone Model LKPW1 with potential for low progesterone results, risking unnecessary supplementation. Affected kits: lots 0259 and above.
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.
Siemens Healthcare is recalling certain IMMULITE 1000 Progesterone test kits because they may produce falsely low progesterone results. This could lead to unnecessary progesterone supplementation for patients. The recall affects specific kit lots and models.
The test may give falsely low progesterone readings on some patient samples. This could cause doctors to add extra progesterone to patients when it's not needed, potentially causing unnecessary side effects.
Patients using the recalled IMMULITE 1000 Progesterone test kits for progesterone testing are most at risk. Healthcare providers who use these kits for patient testing may also be affected.
Check the kit lot number on the IMMULITE 1000 Progesterone test kit. Affected kits have lot numbers 0259 and above. The model number is LKPW1 with SMN number 10381128.
Look for the lot number on the test kit label; affected kits have lot numbers 0259 and above.
The test may produce falsely low progesterone results on some patient samples, which could lead to unnecessary progesterone supplementation.
Check the kit lot number; if it's 0259 or higher, contact Siemens Healthcare for instructions.
No, the recall is for potential inaccurate results, not a physical hazard. The risk is low and does not involve injury.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2289-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2289-2019 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.