Recall Z-2739-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2739-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2015-07-27, terminated 2016-02-26. It names one FDA 510(k) clearance: K010050. Product: ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.. Reason: Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Terminated: 2016-02-26
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K010050 — ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAYBayer Diagnostics Corp.·cleared 2001-02-05

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¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.

Reason for recall

Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

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