BD FocalPoint Slide Profiler Recalled for Temperature Limit Labeling Error
Becton Dickinson is recalling BD FocalPoint Slide Profiler and GS Review Station units because they may not function below 15°C. The agency states this issue has no potential to cause harm.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states that the issue has no potential to cause harm to patients or operators, and the agency classification is Class III, which by definition is unlikely to cause adverse health consequences.
Plain-English summary
Becton Dickinson & Co. is recalling the BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station (Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189). The recall involves 1,063 units distributed worldwide, including the United States, Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium.
The recall was initiated because the devices may not function at the lower end of the labeled operating temperatures (below 15°C). The instrument returns to normal operating conditions when environmental temperatures are at or above 15°C. At lower temperatures, the instrument may fail to initialize, requiring manual screening of slides. The source text explicitly states that this issue has no potential to cause harm to either the patient or the operator, and no results can be released in error because the device does not screen slides when it fails to initialize.
The instrument labeling has been revised to indicate an operating temperature lower limit of 18°C and an operating humidity of 20 to 80% relative humidity. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- 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
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 1,063
Distribution
Distributed nationwide across the United States.
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