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Yingtai

Changsha Yingtai Instrument Co., Ltd · Model GL21M · UDI-DI 06976301910307

JQC

510(k) clearances

592

Adverse events (5 deaths)

Recalls

164

Facilities

Description

Centrifuge is an experimental device that utilizes centrifugal force to separate substances of different densities within a liquid sample. It is widely used in fields such as biomedical science, chemical analysis, molecular biology, and industrial production. By rapidly spinning samples to create a density gradient, centrifuges provide efficient solutions for sample extraction, purification, and concentration. They can generally be categorized into high-speed or low-speed centrifuges, refrigerated or non-refrigerated centrifuges, and floor-standing or benchtop centrifuges.

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 technician and potentially d
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 technician and potentially d
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 technician and potentially d
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 expiry date; the lot
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 expiry date; the lot
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 configuration.
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.