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 and involves a quality control issue (variability) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur iPTH ReadyPack Assay 500 Tests. The recall involves 3,302 kits distributed nationwide. 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 reagent lot numbers are 056301 and 56302. The affected kit lot numbers and expiration dates are: REF 10492369 (61639301, 63607301, 68004301, 70229301, 74126301) and REF 10493616 (62645302, 66612302, 74129302), all expiring on 09 Nov 2011.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- 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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