Class II — Potential Health Hazard

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

STA Compact Max fully automatic clinical analyzer Recalled by Diagnostica Stago, Inc. Due to An internal investigation identified a bug in this...

Date: March 22, 2023
Company: Diagnostica Stago, Inc.
Status: Ongoing
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

STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

Quantity: 5 analyzers

Why Was This Recalled?

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

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