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.
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. 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. Quantity: 139 power supplies Lot/code info: 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 Z663518000336 V23090304 Z663518000341 V23090292 Z663518000365 V23090235 Z663518000358 V23090328 Z663518000353 V23090371 Z663518000382 V23090360 Z663518000369 V23090085 Z663518000380 V23090169 Z663518000351 V23090025 Z663518000348 V23090171 Z663518000356 V23090273 Z663518000378 V23090090 Z663518000345 V23090018 Z663518000367 V23090226 Z663518000385 V23090369 Z663518000376 V23090356 Z663518000379 V23090041 Z663518000354 V23090359 Z663518000384 V23090490 Z663518000386 V23090262 Z663518000388 V23090162 Z6
00382906635181
Official record: FDA (Device enforcement) ↗
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