Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0252-2013·Announced 2012-11-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Diagnostica Stago, Inc.
Category: Medical Device — Clinical Laboratory Equipment
Hazard: mis-labeling
incorrect-data

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.

Same manufacturer · Diagnostica Stago, Inc.

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