Reported Nov 13, 2013 · Terminated

ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating…

Siemens Healthcare Diagnostics, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Intact PTH Calibrator (6 pack)
  • Catalog NumberSMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems
Lot codes and dates
  • Kit Lot14136A16 04 Mar 2014
Amount recalled
595 kits total (5 kits with packaging error)

Where it was sold

Why it was recalled

PTH Calibrator packaged with only high calibrator.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 13, 2014 · Data as of Sep 19, 4:56 PM UTC

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