Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Clinical Chemistry · 21 CFR 862.2050
Recent MDR events
592 adverse event reports on file
- StatSpinEXPRESS 4 CENTRIFUGEJul 27, 2026MalfunctionBeckman Coulter Inc.2050012-2026-00047
- BABSON SAMPLE PREPARATION DEVICEJun 26, 2026MalfunctionBabson Diagnostics3028019212-2026-00002
- BABSON SAMPLE PREPARATION DEVICEApr 28, 2026MalfunctionBabson Diagnostics3028019212-2026-00001
- STATSPIN EXPRESS 4 CENTRIFUGEMar 4, 2026MalfunctionBeckman Coulter Inc.2050012-2026-00014
- EXPRESS 4 CENTRIFUGEFeb 24, 2026MalfunctionBeckman Coulter, Inc2050012-2026-00013
- STATSPINEXPRESS 4 CENTRIFUGEFeb 6, 2026MalfunctionBeckman Coulter Inc.1061932-2026-00005
- PURE PRP SUPRAPHYSIOLOGICDec 23, 2025MalfunctionEmcyte CorporationMW5181131
- EXPRESS 3 CENTRIFUGEJun 25, 2025MalfunctionBeckman Coulter, Inc.2050012-2025-00162
- STATSPINEXPRESS 4 CENTRIFUGEMay 22, 2025MalfunctionBeckman Coulter, Inc.2050012-2025-00154
- AVANTI J-15R CENTRIFUGEFeb 11, 2025MalfunctionBeckman Coulter, Inc3007448124-2025-00002
Event type breakdown
Recalls
16 recall events for this product code
- Iris DiagnosticsTerminatedDec 23, 2014
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4.
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.
Z-0857-2015 · View FDA record ↗ - Global Focus Marketing & DevelopTerminatedJul 27, 2011
Global Focus Marketing and Distribution, Silencer S2200 Centrifuge
Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.
Z-2857-2011 · View FDA record ↗ - StatSpin, Inc., dba Iris Sample ProcessingTerminatedMay 10, 2011
Statspin Express 4 Centrifuge
Rotors may fail due to wire spokes breaking
Z-2169-2011 · View FDA record ↗ - Becton Dickinson & Co.TerminatedMar 11, 2010
CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104
Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.
Z-1069-2010 · View FDA record ↗ - StatSpin, Inc., dba Iris Sample ProcessingTerminatedMar 4, 2010
StatSpin Express 4 Horizontal Centrifuge
Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
Z-0807-2010 · View FDA record ↗ - Biomet, Inc.TerminatedApr 17, 2009
Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biol
A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
Z-1207-2009 · View FDA record ↗ - Iris Sample ProcessingTerminatedNov 21, 2006
StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
Z-0198-2007 · View FDA record ↗ - Cygnus LLCTerminatedFeb 28, 2006
Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Casca
The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.
Z-0563-06 · View FDA record ↗ - Cygnus LLCTerminatedFeb 28, 2006
Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Casc
When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
Z-0564-06 · View FDA record ↗ - Beckman Coulter IncTerminatedJul 20, 2004
Customized Automation Centrifuge, First and Second Generation.
Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.
Z-0975-04 · View FDA record ↗
Registered firms
183 firms currently registered for this product code
Farmaco Quimica Nacional, S.a.
La Esperilla Santo Domingo, DO
Beckman Coulter, Inc.
INDIANAPOLIS, IN, US
Zhuhai Longtime Biological Technology Co., Ltd.
Zhuhai City Guangdong, CN
Globus Medical, Inc.
AUDUBON, PA, US
Beckman Coulter, Inc.
BREA, CA, US
Emcyte Corporation
FORT MYERS, FL, US
Remi Elektrotechnik Ltd.
Dist. Palghar Maharashtra, IN
Ortosistemas, S.a.
Panama, PA
Aspen Surgical Products, Inc.
Caledonia, MI, US
Bsl Co., Ltd.
Busan, KR
Sysmex Ra Co., Ltd, Main Office
Shiojiri Nagano, JP
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Biomet, Inc.
WARSAW, IN, US
Accumax Lab Devices Pvt Ltd
Gandhi nagar Gujarat, IN
Paul E. Danchell A/s
Jyderup Sjalland, DK
Advanced Engineering, Inc.
Huntington, IN, US
Fresenius Kabi Warrendale
WARRENDALE, PA, US
Marina Medical Instruments, Inc.
Davie, FL, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Device Innovation Company Limited
Bangkok Krung Thep Maha Nakhon, TH
Pfau Medizinische Instrumente Gmbh
WANFRIED Hesse, DE
Labpeak Co.,ltd
Jinan Shandong, CN
Joinsmart Biomedical Co., Ltd.
Tapei Taipei, TW
510(k) clearances
38 clearances for this product code
- Emcyte CorporationMay 30, 2019
K183205 · PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
- Harvest Technologies, Corp.Dec 6, 2010
K103340 · SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
- Thermogenesis Corp.Jul 10, 2008
K081345 · AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
- Biomet Manufacturing CorpOct 11, 2007
K071934 · MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
- Perfusion Partners & Assoc., Inc.Jun 20, 2007
K070666 · GENESISCS COMPONENT CONCENTRATING SYSTEM
- Harvest Technologies, Corp.Jan 4, 2006
K052925 · SMARTPREP2 CENTRIFUGE SYSTEM
- Cobe Cardiovascular, Inc.Nov 19, 2004
K042473 · COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- Perfusion Partners & Assoc., Inc.Jul 2, 2003
K024080 · SECQUIRE CELL SEPARATOR