Reported May 17, 2023 · Ongoing
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
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 Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- Lot codes and dates
- UDI-DI036074505898
- Serial Numbers5061471 5061474 0000007405 CF70015885 CF70015886
- Amount recalled
- 5 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.
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