CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report

Advia Centaur¿ iPTH Calibrator recalled

Siemens Healthcare Diagnostics is recalling Advia Centaur¿ iPTH Calibrator, distributed nationwide in the US. The recall was initiated on 14 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCalibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011

Quantity recalled198 (6 pk)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1515-2013
FDA event ID: 65224
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 May 2013
FDA classified: 6 Jun 2013
Reported: 12 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

14 May 2013	Recall initiated by company
6 Jun 2013	Classified by FDA	+23 days
12 Jun 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 65224

Reported	Class	Recall	Company	Reason	Where
12 Jun 2013	CLASS II	Advia Centaur¿ iPTH ReadyPack Assay 500 Tests recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Jun 2013	CLASS II	Advia Centaur iPTH Calibrator recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Jun 2013	CLASS II	Advia Centaur¿ iPTH ReadyPack Assay 100 Tests recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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