Siemens Medical Solutions Diagnostics
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1662-2015 | Class II | Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-acces | March 5, 2015 |
| Z-1658-2015 | Class II | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous | March 5, 2015 |
| Z-1660-2015 | Class II | Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous ra | March 5, 2015 |
| Z-1663-2015 | Class II | Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous | March 5, 2015 |
| Z-1661-2015 | Class II | Direct Water feed Kit, Catalog#10373222 | March 5, 2015 |
| Z-1659-2015 | Class II | Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access ins | March 5, 2015 |
| Z-1832-2014 | Class III | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system | April 25, 2014 |
| Z-1316-2014 | Class II | IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access | February 3, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100910 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | May 11, 2011 |
| K091984 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | October 28, 2009 |
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | January 8, 2009 |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | September 11, 2008 |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | June 27, 2008 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | April 1, 2008 |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | November 5, 2007 |
| K071466 | DCA VANTAGE, MODEL 5075 | October 9, 2007 |
| K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS | October 5, 2007 |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | August 3, 2007 |
| K071017 | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) | May 2, 2007 |