Recall Z-0831-2020— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0831-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-22

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2019-07-22, terminated 2025-02-14. It names one FDA 510(k) clearance: K010050. Product: Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250. Reason: Homocysteine Assay May Cause Elevated Results in the Folate Assay.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-22
Terminated: 2025-02-14
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

Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

Reason for recall

Homocysteine Assay May Cause Elevated Results in the Folate Assay

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