Recall Z-1234-2019— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1234-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-07

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2018-12-07, terminated 2020-04-27. It names one FDA 510(k) clearance: K012777. Product: SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399. 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)..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-12-07
Terminated: 2020-04-27
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K012777 — ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYSBayer Corp.·cleared 2001-10-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.