Reported Jun 17, 2020 · Terminated
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical…
Becton, Dickinson and Company, BD Biosciences
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812
Is this the product you have?
- BD FACS Sample
- Prep Assistant (SPA) II - Product UsageK050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry
- Lot codes and dates
- Catalog (Ref) No. 337170
- Amount recalled
- 95 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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