Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1515-2013·Announced 2013-06-12

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.

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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is limited to performance variability rather than a direct physical or biological threat.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur iPTH Calibrator 6 pk (REF: 10492387, 10630628). These products are intended for in vitro diagnostic use in calibrating Intact PTH assays. The recall involves 198 units (6 pk) distributed nationwide.

The recall was initiated because the iPTH Assay reagent and calibrator lots may have demonstrated higher than anticipated variability. Specific calibrator lot numbers involved are C5601, C5602, and C5603. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining a replacement.

The recalled product

Product: ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: performance-variability

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)

Calibrator Lot Numbers: C5601

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.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

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Same hazard · performance variability