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BD FocalPoint
BECTON, DICKINSON AND COMPANY · Model 491087 · UDI-DI 00382904910877
MNM
Prescription
0
510(k) clearances
158
Adverse events
1
Recalls
3
Facilities
Description
BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-09-21 | Becton Dickinson & Co. | 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 temperatur |
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