Recall Z-1575-2023— Diagnostica Stago, Inc.

Name: FDA recall Z-1575-2023
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: K151867. Product: STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026. 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

K151867 — STA R MAXDiagnostica Stago S.A.S·cleared 2015-08-07

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

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.