Lower risk Medical device recall · FDA · Published September 21, 2018

BD FocalPoint Slide Profiler: May not function below 15°C - No harm to users

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0081-2019Medical device Becton Dickinson ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir, BD Diagnostic Systems · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69839-bd-focalpoint-slide-profiler-may-not-function-below-15-c.

Source Summary by GovInfoNow · govinfonow.com/recall/69839-bd-focalpoint-slide-profiler-may-not-function-below-15-c · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0081-2019

Cite this page

“BD FocalPoint Slide Profiler: May not function below 15°C - No harm to users.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69839-bd-focalpoint-slide-profiler-may-not-function-below-15-c. Based on FDA recall #Z-0081-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2019%22&limit=1).

The FDA announced on 2018-09-21 that Becton Dickinson & Co. is recalling BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station devices because they may not function at temperatures below 15 degrees Celsius, according to the FDA.

How to tell if you have it

Brand: Becton Dickinson
Products: BD FocalPoint Slide Profiler, BD FocalPoint GS Review Station
Catalog Nos.: 490398, 490653, 491085, 491086, 491090, 490189

The hazard

The device may not function at the lower end of the labeled operating temperatures, specifically below 15 degrees Celsius. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 degrees Celsius. This issue has no potential to cause harm to either the patient or the operator.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls of similar products include BD GasP: CO2 Pouch System Recall (2026-04-07) and BD Kiestra Isolate Suspension Cuvette Array Recall (2025-10-23).

How to tell if you have this one

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.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Temperature
Ensure the device is operating at temperatures above 15°C for normal function.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Sep 21, 2018Firm started the recall
Oct 5, 2018FDA classified it Class III
Oct 17, 2018Published in FDA’s Enforcement Report
Apr 25, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Becton Dickinson recalls

Link to this recall

<a href="https://govinfonow.com/recall/69839-bd-focalpoint-slide-profiler-may-not-function-below-15-c">BD FocalPoint Slide Profiler: May not function below 15°C - No harm to users (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0081-2019 (September 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0081-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.