Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1231-2015·Announced 2015-03-11

Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias

Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.

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 involves a bias in test results rather than a direct physical injury or acute health threat, fitting the criteria for a moderate severity recall involving potential adverse health consequences through misdiagnosis or treatment errors.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,719 units of the ADVIA Centaur Systems Progesterone Kit (5-pack Ref). The affected products are identified by Catalog number 02177364 and SMN 10333111. The recall covers specific lot numbers ending in 268 (42590268, 43742268, 44847268) with an expiration date of May 22, 2015.

The recall was initiated because the kits have a high bias on results greater than 30 ng/mL (95.4 nmol/L). This in vitro diagnostic device is used for medical testing, and the bias could affect the accuracy of high-range progesterone measurements.

The affected kits were distributed worldwide, including in the United States and numerous international locations such as Austria, Brazil, Canada, Germany, Japan, and the United Kingdom. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement.

The recalled product

Product: ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-results
mis-diagnosis
Affected units: 1,719

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 (2)

Lot Numbers: 42590268 43742268 44847268 Exp. Date: May 22
2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

See all →

High
Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
Severe
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
Severe
Siemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
High
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
Low
Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12

Same hazard · inaccurate results