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Z-1234-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc — East Walpole, MA

FDA device recall Z-1234-2019 was initiated by Siemens Healthcare Diagnostics, Inc on Dec 7, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 27, 2020). Affected quantity: 10414 kits.

Recall Details

Product Type: Devices
Report Date: May 8, 2019
Initiation Date: Dec 7, 2018
Termination Date: Apr 27, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10414 kits

Product Description

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

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).

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

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1234-2019
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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