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Siemens Medical Solutions Diagnostics Limited

Last updated May 23, 2026

Information

Country: US
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Catalogue (26)

Device	Model / Reference	Registries	Class	Status
IMMULITE® 2000 Systems Microsampling Tubes	10385207	FDA UDI	Class I	Active
IMMULITE® 1000 Systems1000 Sample Cup Caps	10385183	FDA UDI	Class I	Active
IMMULITE® 2000 Systems Microsampling Tube Caps	10385205	FDA UDI	Class I	Active
IMMULITE® 1000 Immunoassay System	10380058	FDA UDI	Class I	Active
IMMULITE® 2000 XPi Immunoassay System	10373214	FDA UDI	Class I	Active
IMMULITE® 2000 Systems Allergen Tube Caps	10282837	FDA UDI	Class I	Active
IMMULITE® 2000 Systems Diluent Tubes	10385210	FDA UDI	Class I	Active
IMMULITE® 2000 Xpi Sample Nesting Cups	10374179	FDA UDI	Class I	Active
IMMULITE® 2000 Systems Allergen Tubes	10282849	FDA UDI	Class I	Active
IMMULITE® 2000 Systems Reaction Tubes	10385206	FDA UDI	Class I	Active
IMMULITE®2000 Systems Diluent Tube Caps	10385211	FDA UDI	Class I	Active
IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS	10380037	FDA UDI	Class I	Active
VersaCell® X3	10793839	FDA UDI	Class I	Active
IMMULITE® 2000 XPi Sample Nesting Cups	10374178	FDA UDI	Class I	Active
Immulite 2500 High Sensitivity C-Reactive Protein, Models L5kcrp (200 Tests), L5kcrp (600 Tests)	K071017	FDA 510(k)	Class II	Active
Dca Vantage, Model 5075	K071466	FDA 510(k)	Class II	Active
Advia Chemistry Microalbumin Calibrators, _2 Calibrators	K072204	FDA 510(k)	Class II	Active
Neonatal Bilirubin On Rapidlab Models 1245 And 1265	K073537	FDA 510(k)	Class I	Active
Immulite 2500 Om-Ma, Model L5kop	K072794	FDA 510(k)	Class II	Active
Immulite 2000 3gallergy Specific Ige Assay Kit, Model L2kun6	K091984	FDA 510(k)	Class II	Active
Advia Chemistry Hemoglobin A1c, Advia Chemistry A1c Calibrators	K081895	FDA 510(k)	Class II	Active
Immulite 2000 3gallergy Specific Ige Assay Kit, Model L2kun6	K100910	FDA 510(k)	Class II	Active
Advia Centaur Cyclosporine Assay And Calibrator	K071455	FDA 510(k)	Class II	Active
Advia Chemistry Enzymatic Creatinine_2	K070727	FDA 510(k)	Class II	Active
Advia Chemistry C-Reactive Protein_2, (crp_2) And Calibrators	K072658	FDA 510(k)	Class II	Active
Immulite Fpsa Assay	P060005	FDA PMA	Class III	Active

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 5, 2015	Z-1659-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Mar 5, 2015	Z-1663-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Mar 5, 2015	Z-1662-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Mar 5, 2015	Z-1660-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Mar 5, 2015	Z-1658-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Mar 5, 2015	Z-1661-2015	—	terminated	The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Apr 25, 2014	Z-1832-2014	—	terminated	The keyboard and monitor may not be properly secured to the monitor arm.
Feb 3, 2014	Z-1316-2014	—	terminated	There is a potential for incorrect results to be reported from processing of a sample tube.
Jan 5, 2009	Z-1399-2009	—	terminated	Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
Jul 21, 2008	Z-0524-2009	—	terminated	Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).
May 21, 2008	Z-2090-2008	—	terminated	The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).
Apr 4, 2008	Z-1715-2008	—	terminated	False negative hCG results due to decreased sensitivity
Jan 12, 2008	Z-1119-2008	—	terminated	Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
Oct 17, 2007	Z-1475-2008	—	terminated	False positive hCG results
Jun 7, 2007	Z-0580-2008	—	terminated	Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.
Jan 15, 2007	Z-0545-2007	—	terminated	Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.