Diagnostica Stago, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1577-2023)

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

Product Classification:

Class II

Date Initiated: March 22, 2023

Date Posted: May 17, 2023

Recall Number: Z-1577-2023

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: 5 analyzers

Code Information:

UDI-DI: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated