Siemens Healthcare recalls IMMULITE 2000 Progesterone devices with potential for low progesterone results, which may lead to unnecessary supplementation. Affected models include US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D).
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 2000 Progesterone devices that may produce falsely low progesterone results. This could lead to unnecessary progesterone supplementation for some patients. The recall affects specific models and kit lots sold in the US and overseas.
The device may produce falsely low progesterone results on some patient samples. This could lead to unnecessary progesterone supplementation decisions for patients. The issue is specific to a subset of samples and not all tests.
Patients using the recalled IMMULITE 2000 Progesterone devices for hormone testing may be at risk of receiving inaccurate results. Healthcare providers who use these devices for progesterone testing are most affected.
Check the model numbers: US models L2KPW2 or L2KPW6, OUS models L2KPW2(D) or L2KPW6(D). Look for US kit lots 510 and above or OUS kit lots D510 and above. Also check the UDI numbers listed in the recall notice.
Identify the model number on your IMMULITE 2000 Progesterone device. Affected models include US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D).
Check the kit lot number on your device. Affected lots are US: 510 and above or OUS: D510 and above.
The IMMULITE 2000 Progesterone device may produce falsely low progesterone results on a subset of patient samples, which could lead to unnecessary progesterone supplementation.
The recall does not require immediate action. Check the model and lot numbers to see if your device is affected. If it is, contact Siemens Healthcare for further instructions.
No, the recall is for potential inaccurate test 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-2290-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2290-2019 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.
