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BD FACSLyric recallZ-0745-2025 · Becton, Dickinson and Company, BD Bio Sciences · initiated Nov 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton, Dickinson and Company, BD Bio Sciences or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

On Nov 18, 2024, BD has identified through complaints 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 caused by BD FACSLyric Flow Cytometer may involve patient specimen loss and/ or delay to provide 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.). Customers are instructed to continue normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use. Ensure the contents of this notification are read and understood. Immediately inspect your inventory for the specific catalog and power supply serial numbers listed above and follow the instructions listed under Actions for Clinical Users . Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification as per FDA requirement.

Recall details

Recall number
Z-0745-2025
Status
Open, Classified
Initiated by the company
Nov 1, 2024
Posted by the FDA
Dec 23, 2024
Recalling firm
Becton, Dickinson and Company, BD Bio Sciences
Quantity
15 power supplies
Product code
OYE
FDA submissions
K170974, K201814
Distribution
Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.

Product description

FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Code information (models, lots, serial numbers)

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662875 UDI-DI code: 00382906628756 Instrument Serial Numbers/ Power Supply Serial Numbers: Z662875000119 V23300114 Z662875000117 V23300192 Z662875000112 V23300098 Z662875000123 V23300321 Z662875000105 V23090179 Z662875000104 V23090157 Z662875000107 V23090507 Z662875000102 V23090029 Z662875000103 V23090114 Z662875000106 V23090177 Z662875000108 V23180127 Z662875000110 V23300074 Z662875000111 V23090430 Z662875000109 V23300294 Z662875000116 V23300051

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95729).

Sources and updates

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