{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Sparks", "address_1": "7 Loveton Cir", "reason_for_recall": "The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.", "address_2": "BD Diagnostic Systems", "product_quantity": "1063", "code_info": "Serial Nos. FP0749 139335 141372 BD0507 BD0508 FP0826 138739 156312 BD0513 FP0060R 159337 159339 159348 FP0705R FPGS-RSBD0089 FPGS-RSBD0098 FP0804 148277 FP0284R BD0509 BD0511 BD0512 FP0549C FP0009R FP0013R FP0065R FP0067R FP0172R FP0220R FP0345 FP0345R FP0446 FP0446R FP0447 FP0447R FP0448R FP0494 FP0723 133215 133219 128928 127632 128051 FP0049R FP0124R 128045 128061 128914 128924 128936 145182 FPGS-RS143333 FPGS-RS143339 FPGS-RS143346 FPGS-RS143347 FPGS-RS143352 FPGS-RS143358 FPGS-RS143359 FPGS-RS143360 FPGSRS143363 FPGS-RS143371 FP0055R FP0264R FP0509R 133206 133212 155447 FP0262R FP0541R 144503 144985 145007 145193 145824 148133 148275 148281 148285 153934 155422 155428 155437 156314 159688 BD0447 FPGS-RS139336 FPGS-RS139337 FPGS-RS139338 FPGS-RS141375 FPGS-RS142653 FPGS-SVR142152 GS-RSBD0251 FP0107R FP0176R FP0472R FP0477R FP0512R 143354 144835 144853 144861 145315 145842 158332 FPGS-RS161528 FPGS-RSBD0281 FPGS-RSBD0293 FP0041R FP0497R 155434 155444 157881 157883 157886 157887 FPGS-RS-BD0179 FP0311R FP0543R 158925 FP0048R 159683 BD0470 BD0482 FPGSRS-BD0039 FPGSRS-BD0048 FP0484R FP0822 142646 142648 143368 144009 144860 144995 158917 BD0450 FP0034R FP0741 FP0747 128919R 133204 134943 134947 FP0811 FP0044R FP0485R 145307 145311 145500 155421 155421 156313 FP0096R 136209 136627 136631 136643 136646 136648 141914 145202 148269 148270 148284 148286 152298 FP0075R FP0492R FP0505R 144500 145184 145504 145822 FP0083R FPGS-RS160653 FPGS-RS160654 FPGSRS160661 FP0153R 142687 142691 143362 143365 143973 143997 144010 144499 148291 FP0091R FP0152R 143338 144025 FP0538R FP0464R 136211 161662 161667 BD0351 FP0735 159674 BD0303 BD0361 FPGS-RS139346 FP0713 713 158918 158923 158929 FP0337R BD0331 BD0504 BD0505 BD0506 BD0525 FPGS-RS138729 FPGS-RS138744 FP0825 148293 141896 144533 FP0108R FP0744 FP0809 FP0823 FP0302R BD0434 FP0340R FP0818 FP0467R FP0476R 143344 143377 144834 145183 145185 145191 145201 145203 145823 148127 148140 148146 157882 158325 159675 BD0469 BD0472 BD0473 BD0474 BD0475 BD0476 BD0477 BD0479 BD0492 BD0521 FP0200R FP0819 143351 144857 145839 FPGS-RSBD0214 FP0482R FP0717 FP0061R FP0145R 137305 137351 137359 137361 137363 137371 137373 137379 137570 137571 137577 137580 137581 138218 138229 138235 138274 138278 138280 138281 142668 144530 144850 145198 145300 145494 145813 145814 145836 145838 145841 145845 148125 152311 152312 156311 158333 159344 159345 FPGS-RBD0138 FPGS-RS137151 FPGS-RS137700 FPGS-RS158331 FPGS-RS159948 FPGS-RS160338 FPGS-RSBD0055 FPGS-RSBD0133 FPGS-RSBD0134 FPGS-RSBD0135 FPGS-RSBD0136 FPGS-RSBD0137 FPGS-RSBD0138 FPGS-RSBD0139 FPGS-RSBD0141 FPGS-RSBD0142 FPGS-RSBD0143 FPGS-RSBD0144 FPGS-RSBD0145 FPGS-RSBD0146 FPGS-RSBD0147 FPGS-RSBD0148 FPGS-RSBD0149 FPGS-RSBD0150 FPGS-RSBD0151 FPGS-RSBD0152 FPGSRSBD0153 FPGS-RSBD0153 FPGS-RSBD0156 FPGSRS-BD0157 FPGS-RSBD0157 FPGS-RSBD0159 FPGS-RSBD0160 FPGS-RSBD0161 FPGS-RSBD0166 FPGS-RSBD0167 FPGS-RSBD0174 FPGSRS-BD0175 FPGS-RSBD0175 FPGS-RSBD0176 FPGS-RSBD0177 FPGS-RSBD0248 FPGS-RSBD0250 FPGS-RSBD0255 FP0393 FP0394 FP0396 FP0399 FP0396 FP0742 FP0748 FP0806 FP0807 128915 133210 135409 135422 136640 136968 136969 136972 136974 136975 136976 136979 136980 136982 136984 136985 136986 136987 136988 136989 136990 136993 136995 136996 136997 137380 144974 144975 144999 151507 152302 FPGS-RS159960 FPGS-RSBD0180 FPGS-RSBD0181 FPGS-RSBD0206 FPGS-RSBD0316 FPGS-RSBD0322 GSRSBD0066 FP0173R FP0183R FP0239R FP0240R FP0241R FP0550R FP0084R FP0293R FP0496R 138214 138216 138220 138223 138224 138225 138226 138232 138233 138236 143336 143350 143356 144982 144989 145200 145826 BD0421 FPGS-RS141371 FPGS-RS141542 FPGS-RS141636 FPGS-RS141840 FPGS-RS141855 FPGS-RS141859 FPGS-RS141870 FPGS-RS141872 FPGS-RS141877 FPGS-RS141882 FP0272R FP0278R FP0289R FP0294R FP0321R FP0452R FP0490R FP0170R FP0242R 145306 145317 145321 155415 155439 157891 158319 FP0498 FP0498R FP0503R FP0381 FP0474R FP0038R FP0281R FP0329R FP0066R FP0077R FP0158R FP0323R FP0371R FP0544R FP0047R FP0112R FP0137R FP0454R FP0282R FP0283R FP0330R FP0462R 142675 145310 FPGS-RS142676 FP0097R 145508 148276 156303 156305 156310 159335 0350R 127626 133203 133207 133213 133216 133218 FPGSRS161191 FP0718 FP0058R 145196 145282 145291 145502 FP0318R FP0304R 139333 139334 139341 139343 141360 FP0068R 128922 128923 128937 128939 131094 132034 FP0149R FP0208R FP0121R FP0473R RSBD0037 RSBD0042 RSBD0047 FP0721 152304 153932 153935 156307 156309 157889 BD0416 BD0485 BD0488 BD0489 BD0493 FP0542C 158315 158321 158323 158326 158327 158334 FP0501C 128944 131095 131096 131154 135410 141907 144509 144980 145294 145318 158921 FPGS-RS142993 FPGSRS143340 FP0116R FP0246R BD0417 BD0478 BD0484 BD0486 BD0487 BD0490 BD0491 FP0356C FP0551C 133214 133222 144020 FPGS-RS143378 714 FP0708 FP0714 157450 BD0342 BD0354 BD0359 BD0433 RS156297 RS156306 FP0812 157879 157880 157888 159676 159677 159678 PM20147RB FP0709 FP0226R 158915 144512 144513 144514 144518 144526 144531 144534 152654 FPGS-RS141533 FPGS-RS141534 FPGS-RS141543 FPGS-RS141545 FPGS-RS141548 FPGS-RS141836 FPGS-RS141837 FPGS-RS141838 FPGS-RS141841 FPGS-RS141842 FPGS-RS141845 FPGS-RS141852 FPGS-RS141853 FPGS-RS141854 FPGS-RS141861 FPGS-RS141864 FPGS-RS141871 FPGS-RS141874 FPGS-RS141875 FPGS-RS141876 FP0221R FP0546C 159347 FPGS-RS141356 FPGS-RS141374 FPGS-RS141899 FPGS-RS141900 FPGS-RS141918 FP0260R FP0336R 144000 144002 144521 145308 145309 145314 155440 FPGS-RS141536 FPGS-RS141544 FPGS-RS141894 FPGS-RS141920 FPGS-RS141923 FPGSRS143993 FP0144R FP0303R 142673 144496 144501 144505 144507 144515 144523 144524 142659 144014 144016 72 RS161664 RSBD0072 FP0292R FP0514R 144532 144840 144859 145209 FPGS-RS142647 FPGS-RS142689 FPGS-RS143013 FPGS-RS143021 FPGS-RS143379 FPGS-RS143381 FP0298R FP0299R FP0465R 141635 FPGSRS143971 FPGSRS143990 FPGSRS143994 152316 152317 153937 155423 155430 155441 FPGSRS141843 FPGSRS141847 FPGSRS141858 FPGSRS141883 FPGSRS141901 FPGSRS143349 FPGSRS143976 FPGSRS144003 FPGSRS152315 FPGS-RS159945 FPGS-RSBD0321 FPGS-RSBD0362 FP00301R 143357 143361 143375 143380 143969 143972 144017 148283 BD0357 FPGSRS142662 FPGSRS142669 FPGSRS142671 FPGSRS142680 FPGSRS142693 FPGSRS142996 FPGSRS143001 FPGSRS143003 FPGSRS143009 FPGSRS143010 FPGSRS143011 FPGSRS143345 FPGSRS143353 FPGSRS143366 FPGSRS143970 FPGSRS159962 FPGSRSBD0223 RSBD0220 FP0014R FP0022R FP0174R 142694 FPGS-RS142998 FPGS-RS143005 FPGS-RS143006 FPGS-RS143007 FPGS-RS143014 FPGS-RS143018 FPGS-RS143019 FPGS-RS143023 FP0268 FP0269R FP0471R 144833 144837 144839 144843 144844 144847 144848 144849 144852 144855 144856 144979 144986 144987 144988 144991 144993 144994 144996 144997 144998 145000 145002 145003 145004 145006 145008 145195 145278 145285 145286 145289 145313 FP0033R FP0036R FP0039R FP0042R FP0052R FP0069R FP0104R FP0198R 142651 142654 142655 142656 143964 144007 158924 323 RS142652 FPGS-RS141361 FPGS-RS141377 FPGS-RS141387 FPGS-RS141388 FP0257R FP0458R 137349 137365 137568 137574 157890 FPGS-RS0296 FPGS-RS141363 FPGS-RS141366 FPGS-RS141367 FPGS-RS141369 FPGS-RS141373 FPGS-RS141381 FPGS-RS141531 FPGS-RS141532 FPGS-RS141535 FPGS-RS141539 FPGS-RS141540 FPGS-RS141547 FPGS-RS161181 FP0099R FP0305R FP0475R 137355 137357 137576 142692 145204 145493 145505 159686 BD0363 BD0377 BD0459 BD0523 BD0528 FPGSRS142660 FPGSRS142665 FPGSRS142672 FPGSRS142678 FPGSRS142686 FPGSRS142688 FPGSRS142695 FPGSRS142984 FPGSRS142988 FPGSRS142989 FPGSRS142990 FPGS-RS142991 FPGSRS142992 FPGSRS143004 FPGSRS143015 FPGSRS143016 FPGSRS143335 FPGSRS143364 FPGSRS143367 FPGSRS143369 FPGSRS160352 FPGSRS161666 FP0029R FP0032R FP0110R FP0127R FP0285R FP0286R FP0287R FPGS-RS143341 FPGS-RS143373 143965 143967 143975 143978 143979 143982 143983 143986 143998 144001 144006 144011 144012 144013 144015 144022 144023 BD0405 FP0159R FP0213R FP0491R FP0532R FP9219R 152300 BD0328 FPGS-RS141355 FPGS-RS141358 FPGS-RS141359 FPGS-RS141364 FPGS-RS141368 FPGS-RS141370 FPGS-RS141378 FPGS-RS141379 FPGS-RS141380 FPGS-RS141385 FPGS-RS141386 FPGS-RS141389 FPGS-RS141537 FPGS-RS141538 FPGS-RS141541 FPGS-RS141546 FPGS-RS141549 FPGS-RS141834 FPGS-RS141846 FPGS-RS141851 FPGS-RS141856 FPGS-RS141863 FPGS-RS141866 FPGS-RS141867 FPGS-RS141868 FPGS-RS141880 FPGS-RS141905 FPGS-RS141910 FPGS-RS141911 FPGS-RS141912 FPGS-RSBD0006 FPGS-RSBD0369 FP0023R FP0054R FP0056R FP0079R FP0080R FP0100R FP0115R FP0095R 128912 128916 128918 128920 128930 128931 128934 128938 128942 145177 145179 148152 152295 153936 156308 159336 BD0345 FP0194R 155424 155427 155431 155436 155443 FP0227R BD0352 FPGSRS161660 FPGSRS161670 FPGSRS161671 FPGSRS161674 FP0339R FP0295R FP0372 143977 143981 145207 152656 FP0463R 158916 FPGS160348 FPGS160351 FP0078R 14012912 153943 153945 156320 BD0207 FP0527R FPGS-RSBD0036 FPGS-RSBD0043 FPGS-RSBD0044 FPGS-RSBD0045 FPGS-RSBD0049 FP0018R 135413 141384 142650 143966 143989 144516 144983 148274 156301 157446 BD0438 BD0445 FP0343R FP0516R FP0719 BD0367 BD0394 BD0397 BD0398 BD0400 BD0401 BD0402 BD0403 FP0307R FP0816 FP0073R 136992 137314 141915 144838 145280 145281 145857 FPGSRS143999 FPGS-RS148292 FPGS-RS159347 FPGS-RS161663 FPGS-RSBD0082 FP0348R FP0349R BD0471 BD0480 BD0481 FP0495C BD0483 FP0817 FP0824 FPGS-RS141633 FPGS-RS141637 FPGS-RS141909 FP0280R 137567 137572 FP0210R 144004 FPGS-RS142663 FPGS-RS142666 FPGS-RS142681 FPGS-RS142683 FP0327R 128927 128933 128943 132023 132033 132036 137298 137318 141913 142997 148132 148135 148136 148137 148141 148272 156317 159679 BD0340 BD0348 BD0355 BD0356 BD0358 BD0364 BD0368 BD0370 BD0371 BD0372 BD0378 FP0808 FP0810 FP0098R FP0520R", "center_classification_date": "20181005", "distribution_pattern": "Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium.", "state": "MD", "product_description": "BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.", "report_date": "20181017", "classification": "Class III", "openfda": {}, "recalling_firm": "Becton Dickinson & Co.", "recall_number": "Z-0081-2019", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "81097", "termination_date": "20190425", "more_code_info": "", "recall_initiation_date": "20180921", "postal_code": "21152-9212", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }