BD FACSLyric 3L 10C with FACSuite Clinical Software recall
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to…
Why was BD FACSLyric 3L 10C with FACSuite Clinical Software recalled?
A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.
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?
UDI: (01)00382906628787(11)180508(21)Z662878000056 serial number: Z662878000056 Work Station SN 2UA80820ZZ UDI: (01)00382906628787(11)180301(21)Z662878000029 serial number: Z662878000029 Work Station SN 2UA80820ZW UDI: (01)00382903389605(11)180315(21)11662382000007 serial number: R662382000007 Work Station SN 2UA8082101
- Product
- BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to…
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 3 devices
- Distribution
- US Distribution in MD.
- Recall date
- February 13, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)