Siemens ADVIA Centaur iPTH Assay Recalled for Variability
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
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 is 'higher than anticipated variability' in an in vitro diagnostic test, which is a quality control issue rather than a direct physical injury or high-risk pathogen exposure. No illnesses or injuries are reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 309 kits of the ADVIA Centaur iPTH ReadyPack Assay (REF 10492368). The product is used for in vitro diagnostic testing to quantitatively determine intact parathyroid hormone (iPTH).
The recall was initiated because specific reagent and calibrator lots demonstrated higher than anticipated variability. The affected units are distributed nationwide. The specific lot numbers involved are Reagent Lot Numbers 056301 and 56302, and Kit Lot Numbers 61655301 and 61950302, both with an expiration date of November 9, 2011.
Healthcare facilities and laboratories should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-consumers are provided as this is a professional in vitro diagnostic product.
The recalled product
- Product
- ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
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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