Device Recall Osmetech OPTICCA, EGlu Cassettes

  • Model / Serial
    All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Austria, Bolivia, France, Greece, Germany, Korea, India, Italy, Jordan, Netherlands, Sweden, Switzerland.
  • Product Description
    Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTI¿E-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Osmetech Inc, 235 Hembree Park Dr, Roswell GA 30076-5700
  • Source
    USFDA