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BD FocalPoint
BECTON, DICKINSON AND COMPANY · Model 491085 · UDI-DI 00382904910853
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
