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Globe Scientific
GLOBE SCIENTIFIC INC. · Model GCH-24-ROT-H · UDI-DI 00840095655705
10
510(k) clearances
592
Adverse events (5 deaths)
16
Recalls
164
Facilities
Description
Hematocrit Rotor for use with GCH Series Hematocrit centrifuge, 24 place, includes lid and reading disk, 12000rpm max
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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Get your free API keyRead the docsData 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.