Z-1575-2023Class II

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

Name: Z-1575-2023 STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers...
Creator: Diagnostica Stago, Inc.
Published: 2023-03-22
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2023-03-22 / Open, Classified / root cause: design

FDA source

Diagnostica Stago, Inc. began a recall of STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 on 2023-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1575-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-22
Posted: 2023-05-10
Recalling firm: Diagnostica Stago, Inc.
Product: STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
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).
Root cause tag: design
FDA root cause: Device Design
Action: Customers were contacted via telephone and an URGENT: MEDICAL DEVICE CORRECTION notification letter beginning 3/22/23. Actions: Stago downgraded your firmware to the previous firmware version as a precaution. Your downgrade has already occurred. Consequently, the risk of this bug only existed during the time period shown above (i.e. from new firmware installation date to the downgrade date). As patient results are interpreted in association with other biological tests, we leave the decision to review previous patient results based on the complete clinical context to your discretion. Our Customer Service team is available to help you carry out your impact analysis. For additional information, please contact your Stago Hotline at 1-800-725-0607.
Quantity in commerce: 6 analyzers
Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
Product codes and lots: UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1575-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1575-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10
Z-1576-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10
Z-1577-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code JPA

K151867Class IISta R MaxDiagnostica Stago S.A.S / cleared 2015-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)