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TrueBond Duet Centrifuge, Pivetal
DRUCKER DIAGNOSTICS · Model 00-056-256-000 · UDI-DI 00810052864907
10
510(k) clearances
592
Adverse events (5 deaths)
16
Recalls
164
Facilities
Description
Veterinary use only general purpose laboratory centrifuge for sample separation. (PIVETAL TRUEFLX STAT, TrueBond Duet)
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.