Device Recall PrepStain GYN 480 Disposable Test Kit with PreCoat Slides

  • Modèle / numéro de série
    100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra, 101008rb, 101008rf, 101008rg, 101008rh, 101008ri, 101008rq, 101008rr, 101008rw, 101008rx, 101008sa, 101008sc, 101008sd, 101008se, 101008sf, 101008sg, 101008sh, 101015rh, 101015rk, 101015rr, 101015rw, 101015rx, 101015sd, 101015se, 101015sf, 101015sg, 101022re, 101022rp, 101022rq, 101022sb, 101022si, 101022sk, 101022sl, 101022so, 101022sr, 101022su, 101029ra, 101029rd, 101029re, 101029rh, 101029ri, 101029rx, 101029sc, 101029sd, 101029sf, 101029sk, 101029ss, 101029st, 101105rl, 101105rm, 101105rt, 101105sb, 101105sd, 101105se, 101105sf,  101105sk, 101105sl, 101105so, 101105ss, 101112ra, 101112re, 101112rl, 101112rt, 101112ru, 101112rv, 101112rz, 101112sa, 101112sf, 101112sg, 101112si, 101112sw, 101112sx, 101119ra, 101119ri, 101119rj, 101119rr, 101119ru, 101119rx, 101119ry, 101119rz, 101119sh, 101119sl, 101119so, 101126ra, 101126rg, 101126rl, 101203ra, 101203rb, 101203rc, 101203rd, 101203rh, 101203rj, 101203rp, 101203rr, 101203rs, 101203ru, 101203rw, 101203si, 101203sl, 101203sn, 101203so, 101203sp, 101210rg,  101210rh, 101210rk, 101210rl, 101210ru, 101210rv, 101210rx, 101210sa, 101210sj, 101217ra, 101217rc, 101217rh, 101217rm, 101217rn, 101217rp, 101217rt, 101217rw, 101217rx, 101224rd, 101224re, 101224rg, 101224rk, 101224rl, 101224rt, 101224ru, 101224rv, 101224rw, 101231rc, 101231rd, 101231rg, 101231rh, 101231ri, 101231rj, 101231ro, 101231rp, 110107rh, 110107ri, 110107rk, 110107rp, 110107rq, 110107rr, 110107rz, 110107sb, 110107sc, 110114rf, 110114rg, 110114rv, 110114rw, 110114rx, 110114ry, 110114sj, 110114sk, 110114sm, 110121rd, 110121rn, 110121rq, 110128rd, 110128rp, 110128rq, 110128rx, 110128sb, 110128sc, 110128sg, 110128sl, 110128sn, 110128sp, 110128sq, 110204ra, 110204rd, 110204rg, 110204rj, 110204rq, 110204rv, 110204rx, 110204sd, 110211rb, 110211rd, 110211rg, 110211rj, 110211rn, 110218rw, 110225rk, 110225rl, 100917rc, 101015sb, 101119sg, 101217ro, 110114sc, 110128sk
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Société-mère du fabricant (2017)
  • Source
    USFDA