Devices

Device Recall enGen (TM) Laboratory Automation System

  • Modèle / numéro de série
    enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Description du dispositif
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- || Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event

Fabricant

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

Device Recall enGen (TM) Laboratory Automation Systems
  • Modèle / numéro de série
    US Serial Numbers/J Numbers: B3ZHP2J/JB3ZHP2J; 736BM4J/J736BM4J; 953289/J953289; 953252/J953252; HJ5K84J/JHJ5K84J; FCM073J/JFCM073J; HPKG25J/JHPKG25J; GWXQ52J/JGWXQ52J; GBX395J/GBX395J; JFBX395J/JFBX395J; FXCBG3J/JFXCBG3J; 3RHC23J/J3RHC23J; JG7BFB5J/JG7BFB5J; 953270/J953270; 953221/J953221; 54FC01J/J54FC01J; 953209/J953209; 5J4B45J/J5J4B45J; 5LQ6Q2J/ J5LQ6Q2J; 2Z3YV1J/J2Z3YV1J; FRKMB2J/JFRKMB2J; 5GV6W2J/5GV6W2J; 7KSC15J/J7KSC15J; 953276/J953276; J2QKG25J/J2QKG25J; DK2BG3J/JDK2BG3J; 953266/J953266; J86PWC5J/ J86PWC5J; JXBQW4J/JJXBQW4J; CXL941J/JCXL941J; J953224/J953224; 36PWC5J/J36PWC5J; 4HX7S4J/J4HX7S4J --- Foreign Serial Numbers/J #s: CRKM82/J31265; 2S5OP0J/J31067; C4Z655J/ J31421; 6VR7K4J/J31401;  90JYS22/J31350; HWJZY4J/JHWJZY4J; J3J4B45J/J3J4B45J; JCT20Q3J/JCT20Q3J; J953234/J953234; J41BCY4J/J41BCY4J; J953244/J953244; J1HX7S4J/ J1HX7S4J; J16XQH4J/J16XQH4J; GWJZY4J/ GWJZY4J; DWXO52J/DWXO52J; 17QP94J/J20022; BGV6W2J/ J20003; H5PWC5J/J271371; 2LSSF5J/J271377; 1K5K84J/ J271264; 8W7WG3J/J85206; 96XQHAJ/ J7023645; 1LSSF5J/J7025050; 86T205J/ J7024893; C3JTP4J/J7023847; D3JTP4J/J7023874; C1JNZ5J/J7023730;  7DRJ44J/J7023728; 7YCF43J/J7023435; 18BFB5J/J7025017; J953222/J953222; J2V6LW4J/J2V6LW4J; J56T205J/J56T205J; BGV6W2J/J57663; 4drj44j/J800103; 6KSC15J/J1801116; FWGFC4J/J75663;  7GV6W2J/J75615; BT9PB5J/ J75666; JT6LW4J/ J30372; 38769917923/JTAINAN1; F2250767/J3055503; F1150698/ J3055496.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.
  • Description du dispositif
    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
  • Manufacturer
    Ortho-Clinical Diagnostics