BD Biosciences Recalls Flow Cytometers for Missing Laser Safety Labeling
BD Biosciences is recalling 2,188 flow cytometers installed between June 2007 and September 2011 because they lack required FDA laser safety labeling.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/labeling issue with no reported injuries.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling 2,188 units of BD Flow Cytometers, including models such as the BD FACSCount, BD FACSCalibur, and BD FACSAria. The recall covers instruments that were installed between June 2007 and September 2011.
The recall was initiated because these specific instruments do not contain the required labeling pursuant to the FDA's Guidance on Laser Products, which mandates conformance with IEC 60825-1 and IEC 60601-2-22 standards (Laser Notice No. 50). The source text does not report any illnesses, injuries, or deaths associated with this labeling deficiency.
The affected products were distributed nationwide. Users of these instruments should check their specific serial numbers against the list provided by the manufacturer to determine if their unit is affected and follow the manufacturer's instructions for corrective action.
The recalled product
- Product
- BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers
- Manufacturer
- BD Biosciences, Systems & Reagents
- Category
- Medical Device — Flow Cytometers
- Hazard
- Affected units
- 2,188
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material No. Serial No. 343202 E0565
- 343202 E3190
- 338960 V96100212
- 338962 V96300187
- 338962 V96300189
- 342975 E97500564
- 338962 V96300231
- 342975 E97500700
- 33300472 H47200110
- 338962 V96300567
- 338960 V96100817
- 338960 V96100911
- 338960 V96100913
- 338962 V96300761
- 338960 V96101255
- 648063 H06300007
- 647793 H79300005
- 343276 E4731
- 337175 V07300249
- 647785 H64778500001
Distribution
Distributed nationwide across the United States.
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