Reagent Kits/ containing flow cells recall
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF…
Why was Reagent Kits/ containing flow cells recalled?
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NextSeq 550Dx UDI-DI: 00816270020125. Kit REF/Flow Cell REF/UDI-DI(Lot): 20028870/20031098/00816270020132(A184824-3, A185016-3, A183951-3, A182816-3, A183339-3, A182533-3, A183950-3, A184531-3, A182413-3, A184058-3, A183613-3, A183211-3, A183612-3, A183826-3, A182302-3, A183449-3, A182298-3, A182532-3, A182299-3, A183830-3, A183118-3, A182301-3, A184359-3, A184727-3); 20028871/20026365/00816270020118(A182717-3, A182051-3, A179804-3, A183343-3); 20064341/20062316/006975709330014(A183402-4, A183550-4); 20064344/20062316/006975709330038(A186185-4, A183170-4, A183404-4, A183555-4, A183557-4); 20064345/20062530/006975709330045(A186074-4, A183278-4, A183405-4, A184005-4); 20064346/20062530/006975709330052(A185054-4, A183279-4, A183409-4, A183568-4, A183569-4, A183570-4, A184776-4); 15050205(20935999, 20956354)
- Product
- Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF…
- Recalling firm
- Illumina, Inc.
- Quantity
- 11916
- Distribution
- Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY, MI and the countries of DK, SA, FR, DE, IT, CN, PL, GB, TH, GR, VN, BE, ES, IL, KR, AU, CH, BG, NL, IE, TW, TR, CZ, HU, NO, FI, JP, SG, LU, AT, AE, ZA, PT, LT, SE.
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)