Siemens Healthcare recalls Epoc BGEM Test Cards due to potential incorrect oxygen level readings, which could lead to unnecessary respiratory support. Affected units include specific model and lot numbers.
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Siemens Healthcare is recalling Epoc BGEM Test Cards that may give inaccurate oxygen level readings. This could lead to incorrect diagnoses and unnecessary respiratory treatments. The recall affects specific model numbers and production lots.
The test cards may produce lower-than-actual oxygen readings (pO2), which could lead to unnecessary respiratory support if the patient is actually oxygenating normally. This risk is specific to the test card's accuracy in measuring oxygen levels.
Patients using these test cards for oxygen level monitoring may receive incorrect results. Healthcare providers and lab staff who use the test cards are most at risk of misdiagnosis.
Check for the model number 10736515 and lot number 11-22005-50 on the test card packaging. The product was sold between 2021 and 2022 with an expiration date of June 22, 2022.
Look for the model number 10736515 and lot number 11-22005-50 on the test card packaging.
The model number is 10736515.
The lot number is 11-22005-50.
The test cards were sold between 2021 and 2022 with an expiration date of June 22, 2022.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1372-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1372-2022 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.
