Recall Z-1822-2025— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1822-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-15

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-04-15. It names one FDA 510(k) clearance: K013406. Product: ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.. Reason: Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-15
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K013406 — ADVIA CENTAUR HOMOCYSTEINE ASSAYBayer Diagnostics Corp.·cleared 2001-12-18

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 HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Reason for recall

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

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