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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BD FACSLyric Flow Cytometers Recalled for Power Supply Failure and Fumes

Agency Publication Date: December 23, 2024
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Summary

Becton, Dickinson and Company (BD) has recalled 239 units of its BD FACSLyric Flow Cytometers due to a defect in the power supply module (part number 650781). The affected power supplies can cause the laboratory instruments to fail to turn on or shut down unexpectedly while in use. If a failure occurs, the device may release fumes that can cause laboratory staff to experience coughing or shortness of breath. Additionally, the failure could lead to the loss of patient specimens or significant delays in test results, potentially requiring patients to undergo painful repeat specimen collection procedures.

Risk

A failure in the internal power supply module can result in the release of harmful fumes into the laboratory environment, posing a risk of inhalation injury to staff. For patients, instrument failure can delay critical diagnostic results or cause specimen loss, necessitating repeat medical procedures that carry risks of pain, bruising, and bleeding.

What You Should Do

  1. This recall affects BD FACSLyric flow cytometer instruments with catalog numbers 662875, 662876, 662877, 662878, and 663518.
  2. Identify if your instrument is affected by checking the catalog number and the power supply module serial number (part number 650781); impacted serial numbers begin with V2309, V2318, or V2330. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: FACSLyric 2L4C Instrument US
Model / REF:
662875
Serial Numbers:
Z662875000119 (Power Supply V23300114)
Z662875000117 (Power Supply V23300192)
Z662875000112 (Power Supply V23300098)
Z662875000123 (Power Supply V23300321)
Z662875000105 (Power Supply V23090179)
Z662875000104 (Power Supply V23090157)
Z662875000107 (Power Supply V23090507)
Z662875000102 (Power Supply V23090029)
Z662875000103 (Power Supply V23090114)
Z662875000106 (Power Supply V23090177)
Z662875000108 (Power Supply V23180127)
Z662875000110 (Power Supply V23300074)
Z662875000111 (Power Supply V23090430)
Z662875000109 (Power Supply V23300294)
Z662875000116 (Power Supply V23300051)
UDI:
00382906628756

Quantity: 15 power supplies

Product: FACSLyric 2L6C Instrument US
Model / REF:
662876
Serial Numbers:
Z662876000065 (Power Supply V23300165)
Z662876000044 (Power Supply V23090245)
Z662876000045 (Power Supply V23090338)
Z662876000048 (Power Supply V23180201)
Z662876000047 (Power Supply V23180258)
Z662876000051 (Power Supply V23180476)
Z662876000050 (Power Supply V23180466)
Z662876000049 (Power Supply V23180113)
Z662876000052 (Power Supply V23180415)
Z662876000053 (Power Supply V23180190)
Z662876000056 (Power Supply V23300354)
Z662876000055 (Power Supply V23300347)
Z662876000057 (Power Supply V23300249)
Z662876000059 (Power Supply V23300174)
Z662876000061 (Power Supply V23300274)
Z662876000062 (Power Supply V23300132)
Z662876000060 (Power Supply V23300286)
Z662876000063 (Power Supply V23300163)
Z662876000066 (Power Supply V23300232)
Z662876000054 (Power Supply V23300408)
UDI:
00382906628763

Quantity: 20 power supplies

Product: FACSLyric 3L8C Instrument US-IVD
Model / REF:
662877
Serial Numbers:
Z662877000064 (Power Supply V23180197)
Z662877000053 (Power Supply V23090166)
Z662877000052 (Power Supply V23090305)
Z662877000054 (Power Supply V23090341)
Z662877000051 (Power Supply V23090060)
Z662877000056 (Power Supply V23090037)
Z662877000058 (Power Supply V23090446)
Z662877000055 (Power Supply V23090190)
Z662877000061 (Power Supply V23180242)
Z662877000057 (Power Supply V23090456)
Z662877000060 (Power Supply V23180454)
Z662877000065 (Power Supply V23180453)
Z662877000062 (Power Supply V23300158)
Z662877000063 (Power Supply V23300110)
Z662877000059 (Power Supply V23180441)
Z662877000068 (Power Supply V23300012)
UDI:
00382906628770

Quantity: 16 power supplies

Product: FACSLyric 3L10C Instrument US-IVD
Model / REF:
662878
Serial Numbers:
Z662878000426 (Power Supply V23180200)
Z662878000412 (Power Supply V23180272)
Z662878000410 (Power Supply V23180312)
Z662878000046 (Power Supply UNK)
Z662878000319 (Power Supply UNK)
Z662878000367 (Power Supply V23090032)
Z662878000373 (Power Supply V23090334)
Z662878000370 (Power Supply V23090030)
Z662878000371 (Power Supply V23090076)
Z662878000377 (Power Supply V23090329)
Z662878000369 (Power Supply V23090021)
Z662878000375 (Power Supply V23090010)
Z662878000372 (Power Supply V23090176)
Z662878000378 (Power Supply V23090048)
Z662878000380 (Power Supply V23090136)
Z662878000374 (Power Supply V23090354)
Z662878000383 (Power Supply V23090365)
Z662878000379 (Power Supply V23090361)
Z662878000401 (Power Supply V23180013)
Z662878000382 (Power Supply V23090191)
Z662878000381 (Power Supply V23090196)
Z662878000421 (Power Supply V23180001)
Z662878000387 (Power Supply V23090396)
Z662878000420 (Power Supply V23180150)
Z662878000425 (Power Supply V23180449)
Z662878000399 (Power Supply V23180007)
Z662878000400 (Power Supply V23090381)
Z662878000422 (Power Supply V23090460)
Z662878000386 (Power Supply V23090409)
Z662878000388 (Power Supply V23090374)
Z662878000390 (Power Supply V23090408)
Z662878000368 (Power Supply V23090036)
Z662878000431 (Power Supply V23300473)
Z662878000432 (Power Supply V23300472)
Z662878000389 (Power Supply V23090387)
Z662878000423 (Power Supply V23180014)
Z662878000454 (Power Supply V23300221)
Z662878000413 (Power Supply V23180117)
Z662878000376 (Power Supply V23090122)
Z662878000455 (Power Supply V23300323)
Z662878000453 (Power Supply V23300273)
Z662878000411 (Power Supply V23180096)
Z662878000385 (Power Supply V23090172)
Z662878000384 (Power Supply V23090499)
Z662878000394 (Power Supply V23090394)
Z662878000395 (Power Supply V23180408)
Z662878000434 (Power Supply V23180118)
Z662878000435 (Power Supply V23300149)
Z662878000111 (Power Supply UNK)
UDI:
00382906628787

Quantity: 49 power supplies

Product: FACSLyric 3L12C Instrument RUO
Model / REF:
663518
Serial Numbers (193):
MP6635180000004 (Power Supply V23180079)
MP6635180000008 (Power Supply V23180205)
MP6635180000005 (Power Supply V23180222)
MP6635180000006 (Power Supply V23180230)
Z663518000594 (Power Supply V23180062)
Z663518000529 (Power Supply V23300356)
Z663518000526 (Power Supply V23300128)
Z663518000470 (Power Supply V23180355)
Z663518000471 (Power Supply V23180343)
Z663518000456 (Power Supply V23090485)
Z663518000433 (Power Supply V23090505)
Z663518000402 (Power Supply V23090220)
Z663518000165 (Power Supply UNK)
Z663518000196 (Power Supply UNK)
Z663518000214 (Power Supply UNK)
Z663518000338 (Power Supply V23090066)
Z663518000342 (Power Supply V23090294)
Z663518000339 (Power Supply V23090178)
Z663518000349 (Power Supply V23090224)
Z663518000350 (Power Supply V23090127)
Z663518000357 (Power Supply V23090035)
Z663518000343 (Power Supply V23090118)
Z663518000346 (Power Supply V23090121)
Z663518000352 (Power Supply V23090319)
Z663518000360 (Power Supply V23090242)
Z663518000355 (Power Supply V23090002)
Z663518000359 (Power Supply V23090351)
Z663518000340 (Power Supply V23090283)
Z663518000337 (Power Supply V23090300)
Z663518000335 (Power Supply V23090301)
Z663518000361 (Power Supply V23090352)
Z663518000362 (Power Supply V23090113)
Z663518000347 (Power Supply V23090077)
Z663518000336 (Power Supply V23090304)
Z663518000341 (Power Supply V23090292)
Z663518000365 (Power Supply V23090235)
Z663518000358 (Power Supply V23090328)
Z663518000353 (Power Supply V23090371)
Z663518000382 (Power Supply V23090360)
Z663518000369 (Power Supply V23090085)
Z663518000380 (Power Supply V23090169)
Z663518000351 (Power Supply V23090025)
Z663518000348 (Power Supply V23090171)
Z663518000356 (Power Supply V23090273)
Z663518000378 (Power Supply V23090090)
Z663518000345 (Power Supply V23090018)
Z663518000367 (Power Supply V23090226)
Z663518000385 (Power Supply V23090369)
Z663518000376 (Power Supply V23090356)
Z663518000379 (Power Supply V23090041)
UDI:
00382906635181

Quantity: 139 power supplies

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95729
Status: Active
Manufacturer: Becton, Dickinson and Company, BD Bio Sciences
Sold By: BD Bio Sciences; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 5 products (15 power supplies; 20 power supplies; 16 power supplies; 49 power supplies; 139 power supplies)
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.