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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACSLyric

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 Class 2 Device Recall BD FACSLyricsee related information
Date Initiated by FirmNovember 01, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0749-2025
Recall Event ID 95729
510(K)NumberK170974 K201814 
Product Classification Flow cytometric reagents and accessories. - Product Code OYE
ProductFACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Code Information 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 Z663518000387 V23090264 Z663518000364 V23090084 Z663518000389 V23090072 Z663518000381 V23090059 Z663518000375 V23090237 Z663518000390 V23090079 Z663518000377 V23090198 Z663518000383 V23090259 Z663518000444 V23180285 Z663518000391 V23090068 Z663518000373 V23090200 Z663518000372 V23090086 Z663518000445 V23090375 Z663518000442 V23180281 Z663518000374 V23090251 Z663518000441 V23180332 Z663518000370 V23090233 Z663518000440 V23180189 Z663518000463 V23180015 Z663518000449 V23090492 Z663518000446 V23180237 Z663518000439 V23180186 Z663518000392 V23090502 Z663518000366 V23090089 Z663518000450 V23090476 Z663518000468 V23180145 Z663518000447 V23180183 Z663518000451 V23090466 Z663518000461 V23090461 Z663518000460 V23180112 Z663518000462 V23180012 Z663518000457 V23090475 Z663518000443 V23180323 Z663518000489 V23180209 Z663518000448 V23090468 Z663518000487 V23180301 Z663518000483 V23300185 Z663518000478 V23180094 Z663518000491 V23300409 Z663518000479 V23180033 Z663518000488 V23180176 Z663518000459 V23090464 Z663518000492 V23180177 Z663518000493 V23300434 Z663518000466 V23180066 Z663518000481 V23300147 Z663518000408 V23090390 Z663518000412 V23090422 Z663518000480 V23180450 Z663518000458 V23090393 Z663518000411 V23090400 Z663518000498 V23180172 Z663518000486 V23180028 Z663518000484 V23180447 Z663518000521 V23300068 Z663518000415 V23090126 Z663518000497 V23180187 Z663518000494 V23180149 Z663518000414 V23090412 Z663518000485 V23180108 Z663518000406 V23090039 Z663518000464 V23180086 Z663518000482 V23180467 Z663518000416 V23090295 Z663518000363 V23090123 Z663518000417 V23090443 Z663518000410 V23090442 Z663518000413 V23090455 Z663518000522 V23300405 Z663518000528 V23300351 Z663518000405 V23090054 Z663518000519 V23300086 Z663518000418 V23090175 Z663518000371 V23090236 Z663518000469 V23180097 Z663518000548 V23300399 Z663518000549 V23180424 Z663518000547 V23300319 Z663518000555 V23300006 Z663518000544 V23300233 Z663518000556 V23300022 Z663518000559 V23300151 Z663518000523 V23300129 Z663518000551 V23180369 Z663518000527 V23300346 Z663518000524 V23300082 Z663518000531 V23300126 Z663518000407 V23090267 Z663518000490 V23300432 Z663518000495 V23180167 Z663518000565 V23300247 Z663518000568 V23300245 Z663518000566 V23300312 Z663518000569 V23300272 Z663518000546 V23180129 Z663518000525 V23300195 Z663518000409 V23090406 Z663518000530 V23300358 Z663518000398 V23090272 Z663518000368 V23090303 Z663518000397 V23090082 Z663518000573 V23300100 Z663518000576 V23300285 Z663518000571 V23300284 Z663518000572 V23300243 Z663518000393 V23090263 Z663518000394 V23090265 Z663518000575 V23300292 Z663518000432 V23090510 Z663518000574 V23300480 Z663518000577 V23300281 Z663518000399 V23090253 Z663518000396 V23090258 Z663518000401 V23090289 Z663518000400 V23090355 Z663518000583 V23300116 Z663518000567 V23300239 Z663518000570 V23300254 Z663518000453 V23090472 Z663518000437 V23090500 Z663518000438 V23090498 Z663518000452 V23090426 Z663518000593 V23300164 Z663518000395 V23090078 Z663518000455 V23180254 Z663518000404 V23090138 Z663518000421 V23090384 Z663518000403 V23090088 Z663518000472 V23180346 Z663518000473 V23180130 Z663518000474 V23180341 Z663518000420 V23090404 Z663518000435 V23090503 Z663518000592 V23180107 Z663518000434 V23090445 Z663518000454 V23180199 Z663518000436 V23090506 Z663518000344 V23090161 Z663518000465 V23180064
FEI Number 3027394506
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Bio Sciences
155 N Mccarthy Blvd
Milpitas CA 95035-5102
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn Nov 18, 2024, BD has identified through complaints 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 caused by BD FACSLyric Flow Cytometer may involve patient specimen loss and/ or delay to provide 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.). Customers are instructed to continue normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use. Ensure the contents of this notification are read and understood. Immediately inspect your inventory for the specific catalog and power supply serial numbers listed above and follow the instructions listed under Actions for Clinical Users . Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification as per FDA requirement.
Quantity in Commerce139 power supplies
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OYE
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