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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1652-2025

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

Publicado el 30 de abril de 2025 · Inicio del retiro: 18 de marzo de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Abbott Laboratories
Distribuidor
Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.
Lote
UDI-DI 00380740017170 SNs: 30039BG 34021BG 34079BG 34108BG 34123BG 34138BG 34140BG 34149BG 34152BG 34161BG 34177BG 34186BG 34232BG 34242BG 34272BG 34288BG 34302BG 34323BG 34339BG 34349BG 34353BG 34354BG 34364BG 34372BG 34391BG 34395BG 34414BG 34433BG 34439BG 34448BG 34451BG 34458BG 34466BG 34468BG 34473BG 34478BG 34488BG 34491BG 34531BG 34533BG 34539BG 34551BG 34555BG 34559BG 34565BG 34566BG 34598BG 34604BG 34605BG 34620BG 34633BG 34634BG 34646BG 34667BG 34669BG 34695BG 34726BG 34734BG 34736BG 34742BG 34744BG 34758BG 34768BG 34788BG 34789BG 34791BG 34793BG 34805BG 34816BG 34837BG 34839BG 34841BG 34844BG 34850BG 34868BG 34878BG 34881BG 34884BG 34888BG 34893BG 34902BG 34903BG 34907BG 34918BG 34927BG 34933BG 34940BG 34942BG 34950BG 34953BG 34957BG 34965BG 34971BG 34974BG 34975BG 34976BG 34980BG 34984BG 34988BG 34997BG 35016BG 35029BG 35045BG 35049BG 35050BG 35056BG 35061BG 35062BG 35066BG 35067BG 35073BG 35077BG 35089BG 35097BG 35102BG 35104BG 35105BG 35111BG 35112BG 35117BG 35127BG 35128BG 35130BG 35135BG 35142BG 35143BG 35148BG 35154BG 35155BG 35161BG 35163BG 35165BG 35167BG 35168BG 35172BG 35173BG 35174BG 35175BG 35176BG 35177BG 35178BG 35179BG 35180BG 35181BG 35182BG 35184BG 35191BG 35192BG 35201BG 35207BG 35217BG 35221BG 35224BG 35253BG 35259BG 35272BG 35273BG 35274BG 35275BG 35276BG 35277BG 35278BG 35279BG 35280BG 35281BG 35285BG 35295BG 35300BG 35304BG 35305BG 35305BG 35307BG 35309BG 35311BG 35317BG 35320BG 35324BG 35334BG 35338BG 35341BG 35344BG 35346BG 35355BG 35370BG 35372BG 35376BG 35377BG 35380BG 35381BG 35383BG 35389BG 35391BG 35396BG 35397BG 35398BG 35401BG 35404BG 35413BG 35417BG 35420BG 35424BG 35439BG 35442BG 35443BG 35449BG 35451BG 35457BG 35470BG 35471BG 35478BG 35480BG 35496BG 35500BG 35507BG 35509BG 35511BG 35513BG 35522BG 35524BG 35525BG 35529BG 35531BG 35534BG 35535BG 35548BG 35550BG 35554BG 35555BG 35556BG 35558BG 35561BG 35563BG 35564BG 35573BG 35578BG 35585BG 35594BG 35597BG 35598BG 35599BG 35600BG 35601BG 35605BG 35626BG 35677BG 35682BG 35688BG 35689BG 35692BG 35694BG 35699BG 35700BG 35701BG 35717BG 35718BG 35730BG 35740BG 35751BG 35752BG 35755BG 35758BG 35760BG 35761BG 35762BG 35763BG 35767BG 35772BG 35778BG 35779BG 35780BG 35785BG 35788BG 35789BG 35796BG 35798BG 35803BG 35804BG 35809BG 35811BG 35819BG 35820BG 35822BG 35825BG 35826BG 35830BG 35835BG 35836BG 35837BG 35839BG 35841BG 35842BG 35844BG 35846BG 35847BG 35848BG 35850BG 35856BG 35858BG 35871BG 35877BG 35878BG 35879BG 35881BG 35891BG 35892BG 35893BG 35905BG 35950BG 35952BG 35953BG 35959BG 35960BG 35962BG 35965BG 35966BG 35969BG 35973BG 35974BG 35976BG 35987BG 35990BG 35993BG 35995BG 36000BG 36002BG 36004BG 36007BG 36008BG 36009BG 36011BG 36012BG 36020BG 36023BG 36024BG 36025BG 36026BG 36029BG 36032BG 36037BG 36042BG 36044BG 36052BG 36055BG 36057BG 36059BG 36060BG 36061BG 36062BG 36063BG 36068BG 36069BG 36072BG 36073BG 36074BG 36075BG 36079BG 36082BG 36089BG 36091BG 36092BG 36093BG 36095BG 36101BG 36102BG 36104BG 36105BG 36111BG 36116BG 36117BG 36119BG 36120BG 36123BG 36124BG 36125BG 36127BG 36130BG 36139BG 36153BG 36155BG 36166BG 36175BG 36178BG 36188BG 36196BG 36197BG 36199BG 36214BG 36216BG 36219BG 36224BG 36230BG 36231BG 36237BG 36249BG 36250BG 36253BG 36256BG 36273BG 36274BG 36275BG 36276BG 36279BG 36282BG 36283BG 36285BG 36287BG 36288BG 36309BG 36310BG 36313BG 36314BG 36317BG 36318BG 36319BG 36320BG 36330BG 36335BG 36339BG 36349BG 36354BG 36357BG 36362BG 36363BG 36367BG 36368BG 36369BG 36370BG 36371BG 36375BG 36377BG 36378BG 36379BG 36380BG 36382BG 36383BG 36384BG 36385BG 36387BG 36388BG 36391BG 36392BG 36394BG 36398BG 36400BG 36401BG 36402BG 36407BG 36408BG 36410BG 36418BG 36424BG 36426BG 36427BG 36428BG 36429BG 36435BG 36437BG 36441BG 36442BG 36447BG 36448BG 36454BG 36455BG 36456BG 36462BG 36464BG 36465BG 36466BG 36467BG 36468BG 36469BG 36471BG 36473BG 36474BG 36478BG 36483BG 36485BG 36487BG 36488BG 36489BG 36497BG 36501BG 36505BG 36507BG 36526BG 36531BG 36537BG 36538BG 36540BG 36541BG 36552BG 36564BG 36566BG 36567BG 36569BG 36570BG 3657
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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