Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.
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 potential inaccuracies in diagnostic results due to temperature sensitivity, which is a moderate risk without reported injuries or fatalities.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Digitoxin (DGTN) test kits. The recall involves 50-test and 250-test kits intended for in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
The recall is due to the operating range of the ADVIA Centaur systems, which is 18°C to 30°C (64.4°F to 86.0°F). A change in room temperature may increase or decrease assay results, depending on the specific assay and system used.
The affected products were distributed worldwide, including nationwide in the USA and internationally to numerous countries. All lot codes are included in this recall. Users should stop using the affected test kits and contact Siemens Healthcare Diagnostics, Inc. for further instructions.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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