Recall Z-0854-2022— Illumina, Inc.
Class II · Completed
Class II FDA medical device recall by Illumina, Inc., initiated 2022-02-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Illumina NextSeq 550Dx, REF: 20005715, CE, IVD. Reason: 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..
- Recalling firm
- Illumina, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-02-22
- Firm location
- San Diego, CA, United States
Product description
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.