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Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
FDA product code JQC · Class 1 · Clinical Chemistry
1,031
Registered devices
592
Adverse events
16
Recalls
38
510(k) clearances
Devices with this code
755VES Centrifuge, Drucker (MTF) — DRUCKER DIAGNOSTICSLW Scientific — LW SCIENTIFIC, INC.Horizon 6 (DC) Centrifuge, Drucker — DRUCKER DIAGNOSTICSHorizon 6 Flex FA Centrifuge, Tropocells Cellenis Estar — DRUCKER DIAGNOSTICSHorizon 6 Flex Centrifuge, Woodley — DRUCKER DIAGNOSTICSDASH Flex 24 Centrifuge, Royal Biologics — DRUCKER DIAGNOSTICSThermo Scientific — Thermo Electron LED GmbH642E Centrifuge, Clinical Pathology — DRUCKER DIAGNOSTICS853VES Centrifuge, Gamma Dynacare — DRUCKER DIAGNOSTICSYingtai — Changsha Yingtai Instrument Co., LtdLW Scientific — LW SCIENTIFIC, INC.Yingtai — Changsha Yingtai Instrument Co., LtdHorizon 12 Flex Centrifuge, Drucker, Brazil — DRUCKER DIAGNOSTICSEBA 200S — Andreas Hettich GmbHSERO 12 Centrifuge, Boekel — DRUCKER DIAGNOSTICSCarrier — Andreas Hettich GmbHThermo Scientific — Thermo Electron LED GmbHHorizon 24 Centrifuge, Sarstedt — DRUCKER DIAGNOSTICSThermo Scientific — Thermo Electron LED GmbHGlobe Scientific — GLOBE SCIENTIFIC INC.Globe Scientific — GLOBE SCIENTIFIC INC.LW Scientific — LW SCIENTIFIC, INC.Globe Scientific — GLOBE SCIENTIFIC INC.Thermo Scientific — Thermo Electron LED GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-06 | LW Scientific, Inc. | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technici |
| 2019-02-06 | LW Scientific, Inc. | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technici |
| 2019-02-06 | LW Scientific, Inc. | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technici |
| 2017-10-20 | Terumo BCT, Inc. | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and e |
| 2017-10-20 | Terumo BCT, Inc. | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and e |
| 2016-02-05 | Beckman Coulter Inc. | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced co |
| 2014-12-03 | Iris Diagnostics | Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time |
| 2011-07-15 | Global Focus Marketing & Develop | Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected. |
| 2010-08-18 | StatSpin, Inc., dba Iris Sample Processing | Rotors may fail due to wire spokes breaking |
| 2010-01-27 | StatSpin, Inc., dba Iris Sample Processing | Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces. |
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