FDA Device Intelligence
Home › DRUCKER DIAGNOSTICS › 755VES MS Centrifuge, Biomet

755VES MS Centrifuge, Biomet

DRUCKER DIAGNOSTICS · Model 00-045-002-001 · UDI-DI 00858092006802

JQC
10
510(k) clearances
615
Adverse events (5 deaths)
18
Recalls
166
Facilities

Description

General purpose laboratory centrifuge for sample separation.

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 multiple pieces dur
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 centrifugation run, resulting i
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 technician and potentially d
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 technician and potentially d
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 technician and potentially d
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 expiry date; the lot
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 expiry date; the lot
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 configuration.
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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.