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

Advia Centaur¿ iPTH ReadyPack Assay 100 Tests recalled

Siemens Healthcare Diagnostics is recalling Advia Centaur¿ iPTH ReadyPack Assay 100 Tests, 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 codesReagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011

Quantity recalled309 (100 test) kits

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-1512-2013
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 ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

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?

Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 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

This product is part of a recall event; the main page for the event is Advia Centaur¿ iPTH Calibrator recalled.

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

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