Devices

Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  Accelerator a3600 -  ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214  FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181  Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095  Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributors in 2 states: NY and IL.
  • 제품 설명
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
  • Manufacturer
    Inpeco S.A.
  • 1 Event

제조사

Inpeco S.A.
  • 제조사 주소
    Inpeco S.A., Via San Gottardo 10, Lugano Switzerland
  • 제조사 모회사 (2017)
    Inpeco Group Sa
  • Source
    USFDA