Device Recall Confirm Clearly Smart

  • Modelo / Serial
    Confirm Clearly Starter Kits UPC Code 3-02340-30136-7 and Confirm Clearly Refills Kit UPC Code 3-02340-30138-1 (all lots including: Confirm Clearly Starter Kits Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611 Confirm Clearly Refills Kits Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610  Special Pack Deal (6 Starter Kits & 6 Refill Kits) Lot number; LH608
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA and Canada
  • Descripción del producto
    Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) || Note: || (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick || (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Mizuho USA, Inc., 12131 Community Rd, Poway CA 92064-8801
  • Source
    USFDA