Reported May 17, 2023 · Ongoing
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
- Lot codes and dates
- UDI-DI036074505901
- Serial NumbersCP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
- Amount recalled
- 6 analyzers
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Diagnostica Stago, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.