CLASS III Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
BD FACSLyric 10C with FACSuite Clinical recalled
Becton, Dickinson and Company, BD Biosciences is recalling BD FACSLyric 10C with FACSuite Clinical, distributed in Maryland. The recall was initiated on 2 Jan 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0792-2019
- FDA event ID
- 81915
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences, San Jose, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 1 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 1 Feb 2019 | Classified by FDA | +30 days |
| 13 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
Where it was distributed
US Distribution in MD.
Questions about this recall
Why was it 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.
Which lots 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
Where was it sold?
US Distribution in MD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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