Reported May 11, 2022 · Ongoing

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol…

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 333 Coney St · East Walpole, MA · 02032-1516

Is this the product you have?

  • ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative
  • determination of estradiol SMN10490889 All lots
Lot codes and dates
  • All lot numbers UDI(01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115
Amount recalled
2,315 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.