BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station — Class III medical device recall Z-0081-2019
Terminated recall by Becton Dickinson & Co., reported 2018-10-17, distributed nationwide. The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrumen
| Recall number | Z-0081-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, JP, KR, MY |
| Quantity | 1,063 |
| Reason classes | labeling, device malfunction |
| Serial numbers | 0350R, 127626, 127632, 128045, 128051, 128061, 128912, 128914, 128915, 128916, 128918, 128919R, 128920, 128922, 128923, 128924, 128927, 128928, 128930, 128931, 128933, 128934, 128936, 128937, 128938 and 475 more |
| Model numbers | 490189, 490398, 490653, 491085, 491086, 491090 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0081-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.