FDA Device recall Z-0749-2025
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 by Becton Dickinson And Bd Bio Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0749-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-01 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Bio Sciences |
| Distribution | US |
Product
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Reason
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.
Identifiers
| code_info | Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number…Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 663518 UDI-DI code: 00382906635181 Instrument Serial Numbers / Power Supply Serial Numbers: MP6635180000004 V23180079 MP6635180000008 V23180205 MP6635180000005 V23180222 MP6635180000006 V23180230 Z663518000594 V23180062 Z663518000529 V23300356 Z663518000526 V23300128 Z663518000470 V23180355 Z663518000471 V23180343 Z663518000456 V23090485 Z663518000433 V23090505 Z663518000402 V23090220 Z663518000165 UNK Z663518000196 UNK Z663518000214 UNK Z663518000338 V23090066 Z663518000342 V23090294 Z663518000339 V23090178 Z663518000349 V23090224 Z663518000350 V23090127 Z663518000357 V23090035 Z663518000343 V23090118 Z663518000346 V23090121 Z663518000352 V23090319 Z663518000360 V23090242 Z663518000355 V23090002 Z663518000359 V23090351 Z663518000340 V23090283 Z663518000337 V23090300 Z663518000335 V23090301 Z663518000361 V23090352 Z663518000362 V23090113 Z663518000347 V23090077 Z6635 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2025%22
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