Z-1235-2019Class II

Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

Name: Z-1235-2019 Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2018-12-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-12-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 on 2018-12-07. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1235-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-07
Posted: 2019-04-27
Terminated: 2020-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Product code: JZO System, Test, Thyroid Autoantibody
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).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued Urgent Medical Device Corrections, to Siemens Healthcare Diagnostics customers in the United States on December 7, 2018 delivered to customers on December 10, 2018. Urgent Field Safety Notices sent out to the country organizations on December 7, 2018 for distribution to customers outside the United States. These letters inform customers that Siemens Healthcare Diagnostics identified a bias with the affected lots of ADVIA Centaur aTG and Atellica IM aTG and action to take and resolution of the issue with new lots of the reagents. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 1489 kits
Distribution: 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
Product codes and lots: Lot Number/Exp. Date: kit lots ending in 317 and lower 72259303 12/13/2018 87903305 1/12/2019 94908307 2/11/2019 96439307 2/11/2019 16824309 3/14/2019 25822309 3/14/2019 28942311 4/27/2019 55978313 5/27/2019 70389317 6/29/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1234-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1235-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1236-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code JZO

K012777Class IIAcs: 180 and Advia Centaur Anti-Thyroglobulin ImmunoassaysBayer Corp. / cleared 2001-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)