STA Satellite Automated Multi-Parameter Analyzer recallZ-0252-2013 · Diagnostica Stago, Inc. · initiated Jun 15, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
Diagnostica Stago sent an Urgent Field Safety Notice dated June 12, 2012, to all affected customers via email return receipt requested on June 15, 2012. Customers were instructed to follow the instructions in the notification and complete the Customer Verification form and return to the Hotline by fax to 973-644-9348. For additional information, customers were instructed to contact the Hotline at 800-725-0607. For questions regarding this recall call 973-631-1200, ext 2044.
Recall details
- Recall number
- Z-0252-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 15, 2012
- Posted by the FDA
- Nov 6, 2012
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 232 units US; 5 units Canada
- Product code
- JPA
- FDA submissions
- K082248
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
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.
Code information (models, lots, serial numbers)
K082248 D089976 Ref 58104 units
Other devices under the same FDA submission
1 device cleared under K082248 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STA Satellite® 58104Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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