Class II — Potential Health Hazard

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

Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA Recalled by Diagnostica Stago, Inc. Due to There have been reports of shortened (T1-T2) results,...

Date: November 14, 2018
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

Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

Quantity: 22342 total

Why Was This Recalled?

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

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