Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-2409-2012·Announced 2012-09-26

Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure

Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates the product is not likely to cause adverse health consequences. The issue is a performance defect (analytical sensitivity) rather than a direct physical hazard, fitting the Moderate severity criteria for low-risk issues.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Prolactin Assay and FSH Calibrator B kits. The recall involves 15,455 kits distributed worldwide, including the United States, Canada, and numerous other countries. The affected products are used for in vitro diagnostic purposes to determine prolactin levels in serum and to calibrate specific assays on the ADVIA Centaur System.

The recall was initiated because the affected lots fail the analytical sensitivity stated in the instructions for use (IFU). The source text specifies that this failure applies to lots below 40. Specific lot numbers and expiration dates for both US and international markets are listed in the recall documentation.

Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on how to return the products. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in…
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: analytical-sensitivity-failure

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 (3)

US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2
8
2102 79197A29 83314C29

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

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Same hazard · analytical sensitivity failure