Reported Mar 16, 2016 · Terminated

Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532…

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?

  • Siemens Healthcare Diagnostic ADVIA Centaur Calibrator
  • E- 6- Pack (Reference) Catalog Number04636889
  • SMN10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following
  • assays using ADVIA Centaur systemsCortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Lot codes and dates
  • Lot codes/Exp Date
    • 91005A42 May 9
    • 2016
    • 53698A42 May 9
    • 2016
Amount recalled
519 pack

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

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

Notice updated Aug 1, 2017 · Data as of Sep 19, 6:01 PM UTC

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