DNA sequencing reagent kits recalled over flow cell gasket leaks
Illumina is recalling 11,916 NextSeq 550Dx reagent kits because flow cell gaskets have a quality issue that may cause leaks during runs, including possible toxic substance exposure to the user.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states leaks may result in toxic substance exposure to the user, and no injuries are reported.
Plain-English summary
Reagent kits containing flow cells, components of the Illumina NextSeq 550Dx Instrument, are being recalled. Affected items include the NextSeq 550Dx High Output Reagent Kit v2.5 in 75-cycle (REF 20028870) and 300-cycle (REF 20028871) versions, together with their flow cell cartridges, and the CN NextSeq 550Dx High Output and Mid Output kits listed in the enforcement record.
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 with a quality issue. Illumina states this may lead to flow cell leaks during runs, which could cause run failures that may result in no or insufficient data output, instrument fluidics clogs, and toxic substance exposure to the user.
The record lists 11,916 units, with the NextSeq 550Dx carrying UDI-DI 00816270020125 and affected kit and flow cell lots listed in the enforcement record. Distribution was worldwide, covering Pennsylvania, New Jersey, California, North Carolina, Utah, Illinois, Maryland, New York, Virginia, West Virginia, South Dakota, Texas, Alabama, South Carolina, Tennessee, Kentucky and Michigan domestically, and a wide range of other countries. The FDA has classified the action as Class II.
Laboratories should quarantine affected lots and follow Illumina's instructions.
The recalled product
- Product
- Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 2002
- Manufacturer
- Illumina, Inc.
- Hazard
- flow-cell-leak
- gasket-defect
- chemical-exposure
- run-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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