Recall Z-0252-2013— Diagnostica Stago, Inc.
Class II · Terminated
Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2012-06-15, terminated 2013-07-19. It names one FDA 510(k) clearance: K082248. Product: STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.. Reason: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿..
- Recalling firm
- Diagnostica Stago, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-15
- Terminated
- 2013-07-19
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Reason for recall
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
Data sourced from openFDA. This site is unofficial and independent of the FDA.