Recall Z-1260-2022— Illumina, Inc.

Name: FDA recall Z-1260-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Class II · Completed

Class II FDA medical device recall by Illumina, Inc., initiated 2022-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: illumina Model NextSeq 550 Dx REF 20005715. Reason: cybersecurity vulnerability.

Recalling firm: Illumina, Inc.
Classification: Class II
Status: Completed
Initiated: 2022-05-03
Firm location: San Diego, CA, United States

Product description

illumina Model NextSeq 550 Dx REF 20005715

Reason for recall

cybersecurity vulnerability

Data sourced from openFDA. This site is unofficial and independent of the FDA.