Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket
Class I - DangerousWhat Should You Do?
- Check if you have this product: Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted. Catalog Number: 662876 UDI-DI code: 00382906628763 Instrument Serial Numbers / Power Supply Serial Numbers: Z662876000065 V23300165 Z662876000044 V23090245 Z662876000045 V23090338 Z662876000048 V23180201 Z662876000047 V23180258 Z662876000051 V23180476 Z662876000050 V23180466 Z662876000049 V23180113 Z662876000052 V23180415 Z662876000053 V23180190 Z662876000056 V23300354 Z662876000055 V23300347 Z662876000057 V23300249 Z662876000059 V23300174 Z662876000061 V23300274 Z662876000062 V23300132 Z662876000060 V23300286 Z662876000063 V23300163 Z662876000066 V23300232 Z662876000054 V23300408
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Becton, Dickinson and Company, BD Bio Sciences
- Reason for Recall:
- On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket
Product Codes/Lot Numbers:
Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted. Catalog Number: 662876 UDI-DI code: 00382906628763 Instrument Serial Numbers / Power Supply Serial Numbers: Z662876000065 V23300165 Z662876000044 V23090245 Z662876000045 V23090338 Z662876000048 V23180201 Z662876000047 V23180258 Z662876000051 V23180476 Z662876000050 V23180466 Z662876000049 V23180113 Z662876000052 V23180415 Z662876000053 V23180190 Z662876000056 V23300354 Z662876000055 V23300347 Z662876000057 V23300249 Z662876000059 V23300174 Z662876000061 V23300274 Z662876000062 V23300132 Z662876000060 V23300286 Z662876000063 V23300163 Z662876000066 V23300232 Z662876000054 V23300408
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0746-2025
Related Recalls
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Becton, Dickinson and Company, BD Bio Sciences
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
BD Trucount Controls, 30 Test - REF: 340335
Becton, Dickinson and Company, BD Bio Sciences
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.