Diagnostica Stago, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1575-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

Product Classification:

Class II

Date Initiated: March 22, 2023

Date Posted: May 17, 2023

Recall Number: Z-1575-2023

Event ID: 92007

Reason for Recall:

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).

Status: Ongoing

Product Quantity: 6 analyzers

Code Information:

UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

Distribution Pattern:

US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated