CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
STA Satellite Automated Multi-Parameter Analyzer This recalled
Diagnostica Stago is recalling STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic, distributed nationwide in the US. The recall was initiated on 15 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0252-2013
- FDA event ID
- 63270
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2012
- FDA classified
- 6 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 15 Jun 2012 | Recall initiated by company | |
| 6 Nov 2012 | Classified by FDA | +144 days |
| 14 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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¿.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Canada
Questions about this recall
Is STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic recalled?
Yes. Diagnostica Stago recalled STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic on 15 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-0252-2013.
Why was it recalled?
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¿.
Which lots are affected?
K082248 D089976 Ref 58104 units
Where was it sold?
Worldwide Distribution - USA (nationwide) and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Patient Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | Digital ECG HD+12, HD+15 recalled by Midmark | Midmark | Labeling Errors | Nationwide |