CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report

SiemensADVIA Centaur aTG (500 test kit) Siemens Material recalled

Siemens Healthcare Diagnostics is recalling SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399, distributed nationwide in the US. The recall was initiated on 7 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number/Exp. Date: (Kit Lots ending in 316 or lower) 68750302 12/13/2018 68751302 12/13/2018 83578304 1/12/2019 91382304 1/12/2019 4642306 2/11/2019 8116306 2/11/2019 19098308 3/14/2019 22635308 3/14/2019 33640310 4/27/2019 39133310 4/27/2019 55625312 5/27/2019 55626312 5/27/2019 56285312 5/27/2019 69206316 6/29/2019 73001316 6/29/2019

Quantity recalled10414 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-1234-2019
FDA event ID: 82521
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 7 Dec 2018
FDA classified: 26 Apr 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

7 Dec 2018	Recall initiated by company
26 Apr 2019	Classified by FDA	+140 days
8 May 2019	Published in enforcement report	+12 days

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

Reason for recall

Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).

Product as listed by the FDA

SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399

Where it was distributed

Nationwide Foreign: Belgium¿¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿ BOGOTA QUARRY BAY, HONG KONG YANGON SANTIAGO DE CHILE MONTEVIDEO BUENOS AIRES LIMA JOINVILLE, SC, BRAZIL Selangor Darul Ehsan Dhaka Ha Noi City Gurgaon, Haryana Hanoi-Hoangmai ASUNCION SHANGHAI Seoul 120 SINGAPORE RIYADH 11411 TAIPEI R.O.C. QUITO HUNTINGWOOD, NEW SOUTH WALES ZAPOPAN Ho Chi Minh-District 3 Huaykwang, Bangkok RIYADH SAN JOSE CHIBA LAVAL HO CHI MINH CITY MANAGUA Gurgaon, Haryana

Nationwide South Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number/Exp. Date: (Kit Lots ending in 316 or lower) 68750302 12/13/2018 68751302 12/13/2018 83578304 1/12/2019 91382304 1/12/2019 4642306 2/11/2019 8116306 2/11/2019 19098308 3/14/2019 22635308 3/14/2019 33640310 4/27/2019 39133310 4/27/2019 55625312 5/27/2019 55626312 5/27/2019 56285312 5/27/2019 69206316 6/29/2019 73001316 6/29/2019

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

3 other products · FDA event 82521

Reported	Class	Recall	Company	Reason	Where
8 May 2019	CLASS II	Siemens Atellica IM aTG (100 test kit) Siemens Material recalled	Siemens Healthcare Diagnostics	Other	Nationwide
8 May 2019	CLASS II	Atellica IM aTG (500 test kit) Siemens Material Number recalled	Siemens Healthcare Diagnostics	Other	Nationwide
8 May 2019	CLASS II	Siemens Advia Centaur aTG (100 test kit) Siemens Material recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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