Food, drugs, devices › Siemens Healthcare Diagnostics

Device recall: ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP

FDA enforcement event 67603 · Class II · initiated 18 Feb 2014 · status Terminated · terminated 6 Mar 2017

DeviceVoluntary: Firm initiated1 product recordTarrytown, NY

FDA enforcement event 67603 is a device recall by Siemens Healthcare Diagnostics of Tarrytown, NY, initiated 18 Feb 2014 and classified Class II, with 1 product record.

FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 6 Mar 2017. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics has 17 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Siemens Healthcare Diagnostics, Tarrytown, NY.

Reason for recall

"Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling."

Distribution

"Nationwide and internationally"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1553-2014	ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.	5,900 units total (1,679 domestically & 4,221 internationally)	Class II	Terminated	14 May 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record in this eventfirm median: 1

17events on this register for the firm

Other enforcement events for Siemens Healthcare Diagnostics

Initiated	Product (first record)	Type	Class	Records
17 Oct 2017	BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184	Device	Class II	1
19 Sep 2014	IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use w	Device	Class II	1
19 Aug 2014	ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a labora	Device	Class II	2
13 Aug 2014	ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525,	Device	Class II	2
6 Aug 2014	ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Numbe	Device	Class II	1
20 Dec 2013	IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products	Device	Class II	2
20 Dec 2013	IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siem	Device	Class II	2
6 Nov 2013	IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380	Device	Class II	1
24 Sep 2013	Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SM	Device	Class II	1
3 Sep 2013	ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for speci	Device	Class II	4

All 17 events for Siemens Healthcare Diagnostics

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide and internationally"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.