Recall Z-1435-2021— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1435-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-02

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-03-02, terminated 2022-06-10. It names one FDA 510(k) clearance: K970431. Product: BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.. Reason: Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-02
Terminated: 2022-06-10
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K970431 — BEHRING COAGULATION SYSTEMBehring Diagnostics, Inc.·cleared 1997-05-05

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

BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.

Reason for recall

Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

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