Reported Jun 12, 2013 · Terminated

ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH…

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¿ iPTH Calibrator 6 pk
  • REF10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberProduct as published
Lot Number/Exp. Date
104923876 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012
106306286 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011
Amount recalled
198 (6 pk)

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

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 Mar 5, 2015 · Data as of Sep 19, 5:35 PM UTC

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