BD FACS 7-color Setup Beads Recalled for Incorrect CD Version
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation/packaging issue (incorrect CD version) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling 96 kits of BD FACS 7-color Setup Beads. The recall was initiated because an incorrect version of the CD was included with the product. These beads are intended for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems.
The affected product is identified by Catalog number 335775 and Lot number 33412. The distribution was worldwide, including the United States (nationwide), Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore, and Taiwan.
Consumers and healthcare facilities should stop using the affected kits and contact BD Biosciences for instructions on how to return or replace the product.
The recalled product
- Product
- BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup…
- Manufacturer
- BD Biosciences, Systems & Reagents
- Hazard
- Affected units
- 96
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 (2)
- Catalog number: 335775
- Lot number 33412.
Distribution
Distributed nationwide across the United States.
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