Reported Jan 1, 2025 · Ongoing
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Becton, Dickinson and Company, BD Bio Sciences
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton, Dickinson and Company, BD Bio Sciences · 155 N Mccarthy Blvd · Milpitas, CA · 95035-5102
Is this the product you have?
FACSLyric 3L12C Instrument RUOCatalog Number 663518UDI 00382906635181
- Lot codes and dates
- Power supply part number 650781 with serial numbers beginning with V2309, V2318
- and V2330 are impacted Catalog Number663518
- UDI-DI code00382906635181 Instrument Serial
- Numbers / Power Supply Serial NumbersUNK Z663518000196 UNK Z663518000214 UNK
MP6635180000004V23180079MP6635180000008V23180205MP6635180000005V23180222MP6635180000006V23180230Z663518000594V23180062Z663518000529V23300356Z663518000526V23300128Z663518000470V23180355Z663518000471V23180343Z663518000456V23090485Z663518000433V23090505Z663518000402V23090220Z663518000165
356 of 356 codes
Z663518000338V23090066Z663518000342V23090294Z663518000339V23090178Z663518000349V23090224Z663518000350V23090127Z663518000357V23090035Z663518000343V23090118Z663518000346V23090121Z663518000352V23090319Z663518000360V23090242Z663518000355V23090002Z663518000359V23090351Z663518000340V23090283Z663518000337V23090300Z663518000335V23090301Z663518000361V23090352Z663518000362V23090113Z663518000347V23090077Z663518000336V23090304Z663518000341V23090292Z663518000365V23090235Z663518000358V23090328Z663518000353V23090371Z663518000382V23090360Z663518000369V23090085Z663518000380V23090169Z663518000351V23090025Z663518000348V23090171Z663518000356V23090273Z663518000378V23090090
- Amount recalled
- 139 power supplies
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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