Summary
The FDA issued a Class II for Illumina NextSeq 550Dx, REF: 20005715, CE, IVD by Illumina, Inc.. Reason: There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module .
Details
Source
Device Recall
External ID
Z-0854-2022
Action Date
2022-04-06
Status
Completed
Category
device
Product Description
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Lot/Code Info: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Quantity Affected: 674 instruments
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 Arab Emirates United Kingdom Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-22
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Illumina, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Illumina, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Illumina, Inc. have FDA actions?
Illumina, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0854-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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