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TrueBond Duet Centrifuge, Pivetal

DRUCKER DIAGNOSTICS · Model 00-056-256-000 · UDI-DI 00810052864907

JQC

510(k) clearances

615

Adverse events (5 deaths)

Recalls

166

Facilities

Description

Veterinary use only general purpose laboratory centrifuge for sample separation. (PIVETAL TRUEFLX STAT, TrueBond Duet)

Recalls

Date	Firm	Reason
2026-09-21	Beckman 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 multiple pieces dur
2026-09-21	Beckman 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 centrifugation run, resulting i
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.

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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.