FDA Device recall Z-0081-2019
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station
- FDA Device
- Class III
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class III recall of BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station by Becton Dickinson And, citing 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 temperatu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0081-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-21 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Serial Nos. FP0749 139335 141372 BD0507 BD0508 FP0826 138739 156312 BD0513 FP0060R 159337 159339 159348 FP…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2019%22
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