Diagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts
Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect secondary unit printouts (INR) while primary units remain correct, representing a risk of misinterpretation but not an immediate physical injury or confirmed adverse health consequence.
Plain-English summary
Diagnostica Stago, Inc. is recalling 237 units of the STA Satellite Automated Multi-Parameter Analyzer. The recall affects 232 units distributed in the United States and 5 units in Canada. This clinical instrument is used to test human plasma to aid in the diagnosis of coagulation abnormalities or to monitor anticoagulant therapy.
The recall was initiated following a single customer complaint that incorrect International Normalized Ratio (INR) values were occasionally printed for Prothrombin Time (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 device.
Affected units are identified by the codes K082248 and D089976, with reference number 58104. Users of the STA Satellite Automated Multi-Parameter Analyzer should contact Diagnostica Stago, Inc. for further instructions on how to proceed with the recall.
The recalled product
- 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 ther
- Manufacturer
- Diagnostica Stago, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- K082248 D089976 Ref 58104 units
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Diagnostica Stago, Inc.
See all →- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighStago free protein S assay may underestimate normal range results
FDA (Devices) · 2026-03-11
- HighLucky Ice mouthwash recalled over insanitary conditions at a distribution center
FDA (Devices) · 2026-01-21
- HighD-Dimer test reagents recalled over potential underestimation of measured levels
FDA (Devices) · 2025-10-22
- ModerateFibrinogen test kits recalled over potential cross-contamination in heparin assays
FDA (Devices) · 2025-09-03
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02