Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Stago IVD Recalled by Diagnostica Stago, Inc. Due to Diagnostica Stago Inc. received some customer complaints regarding...

Date: July 18, 2014
Company: Diagnostica Stago, 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 Diagnostica Stago, Inc. directly.

Affected Products

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

Quantity: 514 kits

Why Was This Recalled?

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Diagnostica Stago, Inc.

Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.

Related Recalls

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