BD FACS Sample Prep Assistant recall
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD…
Why was BD FACS Sample Prep Assistant recalled?
The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog (Ref) No. 337170
- Product
- BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD…
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 95 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, CO,CT, GA, IL, MA, MI, MD, NC, NH,NJ, NY, OH, PA, TN, TX, VA, and VT. The countries of Australia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Europe, Hong Kong, India, Italy, Jamaica, Japan, Kazakhstan, Malaysia, Martinique, Mexico, New Zealand, Nicaragua, Peru, Puerto Rico (US), Romania, Russia, Singapore, South Africa, South Korea, Swaziland, Switzerland, Turkey, US, Vietnam.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)