STA Compact Max fully automatic clinical analyzer recall
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Why was STA Compact Max fully automatic clinical analyzer 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886
- Product
- STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 5 analyzers
- Distribution
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- Recall date
- May 17, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)