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Devices
Device Recall PrepStain GYN 480 Disposable Test Kit with PreCoat Slides
Model / Serial
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
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Manufacturer
Tripath Imaging, Inc.
1 Event
Recall of Device Recall PrepStain GYN 480 Disposable Test Kit with PreCoat Slides
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Manufacturer
Tripath Imaging, Inc.
Manufacturer Address
Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA
Language
English
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