Agency classClass IIOur severity:High FDA (Devices)·Z-0859-2015·Announced 2014-12-31

Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk

Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a mechanical defect (tubing crack) without reported injuries or illnesses in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur (including refurbished units) used for professional in vitro diagnostic tests in laboratories. The recall involves 10,515 units distributed nationwide, including Puerto Rico and all 50 states.

The recall is due to a potential defect where a slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. This issue is identified as an FDA Class II recall.

Healthcare facilities and laboratories should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to address the defect. The source text does not specify specific consumer actions beyond the manufacturer's recall process.

The recalled product

Product: ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Analyzer
Hazard: mechanical-defect
tubing-crack
Affected units: 10,515

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 (20)

Product Codes: 10284980
10286140
10309524
10309525
10310210
10313282
10314322
10316248
10316372
10316968
10317060
10317403
10319111
10319433
10320929
10321568
10322149
10322731
10323204
10325015

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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 · mechanical defect