CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report

STA R Max fully automatic clinical instrument designed recalled

Diagnostica Stago is recalling STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

Quantity recalled6 analyzers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1575-2023
FDA event ID: 92007
Recalling firm: Diagnostica Stago, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 22 Mar 2023
FDA classified: 10 May 2023
Reported: 17 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Mar 2023	Recall initiated by company
10 May 2023	Classified by FDA	+49 days
17 May 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Illinois Massachusetts Minnesota Nebraska Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 92007

This product is part of a recall event; the main page for the event is STA Compact Automated Multi-Parametric Analyzer recalled.

Reported	Class	Recall	Company	Reason	Where
17 May 2023	CLASS II	STA Compact Automated Multi-Parametric Analyzer recalled	Diagnostica Stago	Other	Nationwide
17 May 2023	CLASS II	STA Compact Max fully automatic clinical analyzer recalled	Diagnostica Stago	Other	Nationwide

More recalls from Diagnostica Stago

All 27

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
25 Mar 2026Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
11 Mar 2026Device	CLASS II	STA Liatest Free Protein recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	Asserachrom HPIA recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Other	Nationwide

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