Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits
Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test 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, and the hazard involves potential assay result variability due to temperature, which is a moderate risk without reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Theophylline 2 (THE02) assay kits. The recall covers 250-test and 50-test kits intended for in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
The recall was initiated because the operating range of the ADVIA Centaur systems 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 United States and internationally to numerous countries. All lot codes are included in the recall. Users should contact Siemens Healthcare Diagnostics, Inc. for further instructions.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP…
- 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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