Retiro De Equipo (Recall) de Device Recall enGen (TM) Laboratory Automation Systems

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ortho-Clinical Diagnostics.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Software anomaly; thermo-fisher scientific initially discovered and ortho-clinical diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample ids involving the communication between engen tcautomation (tca) bypass modules (manufactured by thermo-fisher scientific) and the vitros analyzers. to date, no occurrences of this issue have been observed on orthos engen(tm) systems. sample ids may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through inout communication device, triggered by a specific set of events occurring between the bypass module and the analyzer. --- all of the following conditions must be present for the issue to potentially occur: (1.) the bypass module is in the process of positioning sample a at the aspiration position, and (2.) at least two additional sample tubes (samples b and c) are waiting to be aspirated in the bypass module queue, and (3.) a radio frequency identification (rfid) tag read failure occurs on the sample a carrier, and (4.) the vitros system is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- if the software anomaly occurs and the issue is present, the sample id in the inout communication device software queue becomes asynchronous with the actual sample id physical queue, and the vitros assay result will be reported for the wrong sample id. all subsequent samples will have miss-associated results until the bypass module is reset or the queue is empty. --- this issue could potentially miss-associate a sample/patient id with a test result of a different sample. depending on the test involved, patients health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention. to date, no patient harm was reported related to this product issue.
  • Acción
    On 3/8/2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-059, dated 3/8/2017) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all enGen customers to inform them of the issue and provide them instructions on how to monitor and detect if the issue has potentially occurred. For questions or additional information, please contact Ortho Care Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on 3/8/2017 of the issue and instructed to notify their consignees of the issue and appropriate actions to take.


  • 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


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