Recall Z-2169-2013— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2169-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-07-25, terminated 2015-06-12. It names one FDA 510(k) clearance: K010050. Product: ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.. Reason: Calibration failures and/or significant negative shifts in quality control (QC) and patient results..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Terminated: 2015-06-12
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 (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

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