Recall Z-1577-2023— Diagnostica Stago, Inc.

Name: FDA recall Z-1577-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-22

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2023-03-22. It names one FDA 510(k) clearance: K130090. Product: STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612. Reason: 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)..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-22
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K130090 — STA COMPACT MAXDiagnostica Stago, Incorporated·cleared 2013-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.