CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report

Advia Centaur HCY Calibrator recalled by Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics is recalling Advia Centaur HCY Calibrator, distributed nationwide in the US. The recall was initiated on 15 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSiemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79

Quantity recalled1,072 packs (2,144 units) - 156 packs US, 916 packs OUS

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-1822-2025
FDA event ID: 96693
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Apr 2025
FDA classified: 27 May 2025
Reported: 4 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

15 Apr 2025	Recall initiated by company
27 May 2025	Classified by FDA	+42 days
4 Jun 2025	Published in enforcement report	+8 days

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

Reason for recall

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

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 HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Where it was distributed

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Vatikan City, Zaire.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Kentucky Massachusetts Maryland Maine Michigan Missouri Montana

Questions about this recall

Why was it recalled?

Which lots are affected?

Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79

Where was it sold?

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

1 other product · FDA event 96693

This product is part of a recall event; the main page for the event is Atellica IM Homocysteine Calibrator recalled.

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025	CLASS II	Atellica IM Homocysteine Calibrator recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

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