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.

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.

On September 21, 2018, the firm,BD, notified its customers via a "MEDICAL DEVICE PRODUCT ADVISORY" letter. The letter described the product issue, provided corrected instrument labels, and advised customers to take the following actions: 1. Complete the attached Customer Response Form and return to the BD contact noted on the form via Email: [email protected] Fax to: 410-316-4258 whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Using the enclosed label(s), affix a corrected instrument label onto each of your BD FocalPoint Slide Profiler instrument(s) over top of the existing label. The instrument label will be located on the back of your FocalPoint instrument. Note: The instrument labels for the BD FocalPoint GS Review Station are correct and do NOT need to be replaced. 3. Continue to use your FocalPoint per your normal facility procedures and guidelines. 4. Share this Advisory with all users of the FocalPoint within your facility to ensure awareness. 5. Place a copy of this letter in your manual for reference or access the revised Users Manual online a t www.e-labeling.eu/bdx500011292. BD has updated the FocalPoint users manual and labeling with the corrected environmental conditions. If you have further questions, please contact BD Customer Support at 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.