Device Recall enGen (TM) Laboratory Automation Systems

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    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.
  • Descripción del producto
    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source