Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2014-12-23TerminatedComponent design/selection

  RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

  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.

• 2011-07-27TerminatedNonconforming Material/Component

  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.

• 2011-05-10TerminatedDevice Design

  Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes

  Rotors may fail due to wire spokes breaking

• 2010-03-11TerminatedNonconforming Material/Component

  CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.

  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.

• 2010-03-04TerminatedDevice Design

  StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.

  Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.

• 2009-04-17TerminatedProcess control

  Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

  A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.

• 2006-11-21TerminatedOther

  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.

• 2006-02-28TerminatedOther

  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 Cascade.

  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.

• 2006-02-28TerminatedOther

  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 Cascade.

  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.

• 2004-07-20TerminatedOther

  Customized Automation Centrifuge, First and Second Generation.

  Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.