Siemens ADVIA Centaur Calibrator U Recalled for Analytical Sensitivity Failure
Siemens is recalling ADVIA Centaur Calibrator U kits due to failure of analytical sensitivity and drift from internal standardization.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a technical performance failure (analytical sensitivity) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,248 kits of the ADVIA Centaur Calibrator U. This product is used for in vitro diagnostic purposes to calibrate Myoglobin and cTnl assays on ADVIA Centaur systems.
The recall is being conducted because of a failure of analytical sensitivity and a drift from the internal standardization in specific kit lots. The affected lots are identified by lot numbers ending in 63 and 64, specifically: 65710A63, 77825A63, 99481A64, 08835A64, and 22955A64.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, Chile, China, Ecuador, India, Japan, Korea, Mexico, Malaysia, Peru, the Philippines, Saudi Arabia, Singapore, Taiwan, Vietnam, and South Africa. Users should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 2,248
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 (5)
- Kit Lots ending in 63 and 64 as follows: 65710A63
- 77825A63
- 99481A64
- 08835A64
- 22955A64
Distribution
Distributed nationwide across the United States.
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