FDA Class II Recall: FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI… by Becton, Dickinson and Company, BD Bio Sciences — Recall Details

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of 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. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Becton, Dickinson and Company, BD Bio Sciences. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Becton, Dickinson and Company, BD Bio Sciences should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Becton, Dickinson and Company, BD Bio Sciences directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Becton, Dickinson and Company, BD Bio Sciences’s FDA history

Argus HQ has recorded 10 total FDA actions tied to Becton, Dickinson and Company, BD Bio Sciences: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 003 recalled?

Yes. FDA lists a Class II recall by Becton, Dickinson and Company, BD Bio Sciences for 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., reported 20250101, with status "Ongoing." FDA recall number: Z-0745-2025.

What is the recall class for Becton, Dickinson and Company, BD Bio Sciences's recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 003 recalled?

FDA's recall record states the reason as: 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

Related enforcement actions

• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 340335 →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytom… →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Use… →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI… →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787… →
• Recall: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 T… →