Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
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 source text does not report any hospitalizations, injuries, or illnesses, and the hazard is described as higher than anticipated variability rather than a direct physical danger, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur iPTH Calibrator 2 pk (REF 10492394). The product is used for in vitro diagnostic purposes to calibrate Intact PTH assays. The recall involves 99 units (2 pk) distributed nationwide.
The recall was initiated because the iPTH Assay reagent and calibrator lots may have demonstrated higher than anticipated variability. The affected calibrator lot numbers are C5601 and C5602. The associated kit lot numbers and expiration dates are 61405A01, 66517A02, 66611A02, and 71997C02, all expiring on 27 Oct 2011.
This recall is classified as Class II by the U.S. Food and Drug Administration. Users of these products should contact Siemens Healthcare Diagnostics for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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