Recall Z-1259-2022— Illumina, Inc.

Name: FDA recall Z-1259-2022
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 REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx. 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 REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

Reason for recall

cybersecurity vulnerability

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