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Terminated

Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

FDA Recall Z-1236-2019 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJZO
Date Initiated2018-12-07
Date Terminated2020-04-27
Product Quantity114 kits

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).

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012777ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYSBayer Corp. · 2001-10-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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