FDA (Devices) recall action 89953
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test results.
Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.
An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.
Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.
Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.
Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.