Recall Z-1991-2014— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1991-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-05-30, terminated 2016-02-26. It names one FDA 510(k) clearance: K053020. Product: ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790. Reason: The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-05-30
Terminated: 2016-02-26
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEMBayer Healthcare, LLC·cleared 2005-12-30

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

ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790

Reason for recall

The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.

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