FACSLyric 2L4C Instrument US — Class II medical device recall Z-0745-2025
Ongoing recall by Becton, Dickinson and Company, BD Bio Sciences, reported 2025-01-01, distributed nationwide. On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replace
| Recall number | Z-0745-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA, United States |
| Recall initiated | 2024-11-01 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, CR, SG, TH |
| Quantity | 15 power |
| UPC / GTIN / UDI-DI | 00382906628756, 00662875000105, 00662875000112 |
| Serial numbers | V23090029, V23090114, V23090157, V23090177, V23090179, V23090430, V23090507, V23180127, V23300051, V23300074, V23300098, V23300114, V23300192, V23300294, V23300321, Z662875000102, Z662875000103, Z662875000104, Z662875000105, Z662875000106, Z662875000107, Z662875000108, Z662875000109, Z662875000110, Z662875000111 and 5 more |
| Model numbers | 650781, 662875 |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0745-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.