Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BCS(R) Behring Coagulation System Recalled by Siemens Healthcare Diagnostics, Inc. Due to Firm has confirmed that if the Cleaner SCS...

Date: December 1, 2010
Company: Siemens Healthcare Diagnostics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.

Affected Products

BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies

Quantity: 186

Why Was This Recalled?

Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report