Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Check against the official notice below — it lists the full affected range.
Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers distributed across the United States and internationally due to a potential short circuit hazard. The short circuit may occur shortly after the circuit board or imaging module is disconnected and reconnected if the ribbon cable is not fully reconnected. When this happens, the device becomes inoperable.
The affected instruments have lot numbers NDX550110 through NDX550843. The recall document does not specify what remedy or action consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
Reason for recall: There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable. Distribution: US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Ara Quantity: 674 instruments Lot/code info: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.