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Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

FDA product code JQC · Class 1 · Clinical Chemistry

1,078
Registered devices
615
Adverse events
18
Recalls
38
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-09-21Beckman Coulter, Inc.Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into
2026-09-21Beckman Coulter, Inc.Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugat
2019-02-06LW 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
2019-02-06LW 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
2019-02-06LW 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
2017-10-20Terumo 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
2017-10-20Terumo 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
2016-02-05Beckman 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
2014-12-03Iris DiagnosticsIris 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
2011-07-15Global Focus Marketing & DevelopPotential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.

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