Siemens Medical Solutions Diagnostics
Siemens Medical Solutions Diagnostics holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2011, with 8 FDA device recalls on record.
Top product codes for Siemens Medical Solutions Diagnostics
FDA recalls by Siemens Medical Solutions Diagnostics
- Z-1658-2015 — 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.
- Z-1662-2015 — Water Feed Kit, Catalog#10288216,#10389714. 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.
- Z-1663-2015 — Liquid Waste Bottle Kit, Catalog#10386287. 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.
- Z-1661-2015 — Direct Water feed Kit, Catalog#10373222
- Z-1659-2015 — Liquid Waste Bottle, Catalog#10291587. 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.
- Z-1660-2015 — Accessory Kit, Catalog#10282965, #10373217,#10286080. 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.
- Z-1832-2014 — 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.
- Z-1316-2014 — 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 interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Siemens Medical Solutions Diagnostics
- K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
- K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP
- K071466 — DCA VANTAGE, MODEL 5075
- K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
- K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.