STA R Max fully automatic clinical instrument designed recall
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Why was STA R Max fully automatic clinical instrument designed 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: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
- Product
- STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 6 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)