Siemens Medical Solutions Diagnostics

FDA recalling firm · 3 enforcement events · 8 product records · 2014–2015 · NJ

Siemens Medical Solutions Diagnostics has 3 FDA enforcement events on this register (8 product records) between 2014 and 2015: 3 device; the busiest year was 2014 with 2.

0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
5 Mar 2015	Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.	Device	Class II	6	Terminated
25 Apr 2014	VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.	Device	Class III	1	Terminated
3 Feb 2014	IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an…	Device	Class II	1	Terminated

By type and class

Device3

Class II2

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Siemens Medical Solutions Diagnostics by year initiated.

Questions and answers

How many FDA recalls has Siemens Medical Solutions Diagnostics had?

3 enforcement events (8 product records) on this register, 2014–2015: 3 device.

Are any Siemens Medical Solutions Diagnostics recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Siemens Medical Solutions Diagnostics recalls?

2 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.