FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
- Recall number
- Z-1233-2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
- Status
- Terminated
- Initiated
- 2018-12-07
- Posted
- not on file
- Terminated
- 2020-04-27
- Reason
- 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
- 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
- 10673 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
- Lot, serial or model codes
- Lot Number/Exp. Date: 68748302 12/13/2018 68749302 12/13/2018 83577304 1/12/2019 88637304 1/12/2019 5610306 2/11/2019 96436306 2/11/2019 19097308 3/14/2019 31866310 4/27/2019 45386310 4/27/2019 55627312 5/27/2019 69208316 6/29/2019 73000316 6/29/2019
- 510(k) numbers
- ["K012777"]
- PMA numbers
- not on file
- Product code
- JZO
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28