BD recalls FocalPoint Slide Profiler and GS Review Station models with catalog numbers 490398, 490653, 491085, 491086, 491090, and others. The device may not function at temperatures below 15°C, but this issue does not cause harm to patients or users. Labeling has been updated to indicate a minimum operating temperature of 18°C.
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.
Becton Dickinson is recalling their FocalPoint Slide Profiler and FocalPoint GS Review Station devices. These products may not function properly when temperatures drop below 15°C, but the issue does not cause harm to patients or users. The device will return to normal operation when temperatures rise above 15°C.
The device may fail to initialize at temperatures below 15°C, requiring manual screening of slides. However, this does not pose a risk of injury or harm to patients or users. The device returns to normal operation when temperatures rise above 15°C.
Users of the BD FocalPoint Slide Profiler and FocalPoint GS Review Station devices with the listed catalog numbers and serial numbers are affected. The risk is minimal as the issue does not cause harm to patients or users.
Check for catalog numbers 490398, 490653, 491085, 491086, 491090, and other numbers listed in the recall notice. The device also has specific serial numbers that can be found in the product details.
Ensure the device is operating at temperatures above 15°C for normal function.
No, the issue does not cause harm to patients or users. The device may not function below 15°C but will return to normal when temperatures rise above 15°C.
If the device is not functioning at temperatures below 15°C, it may require manual screening of slides. No action is needed if the device is operating above 15°C.
Check the catalog numbers listed in the recall notice (e.g., 490398, 490653, 491085, 491086, 491090) or the serial numbers provided in the product details.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0081-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0081-2019 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
