Recall Record

San Diego, CA, United States

Illumina, Inc. recalls

5 recalls recorded since 2018, most recently on 28 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
28 October 2025
Reason
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Distribution
Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT, IL, MD, NY, VA, WV, SD, TX, AL, SC, TN, KY, MI and the countries of DK, SA, FR, DE, IT, CN, PL, GB, TH, GR, VN, BE, ES, IL, KR, AU, CH, BG, NL, IE, TW, TR, CZ, HU, NO, FI, JP, SG, LU, AT, AE, ZA, PT, LT, SE.
Initiated
Voluntary: Firm initiated
Recall number
Z-0884-2026

Ongoing Class II Medical devices

Recall started
17 September 2024
Reason
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
Distribution
Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA, MA, NJ, MD and the countries of Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United Kingdom, Czech Republic, Singapore, Austria, Poland, France, Germany, Finland, Switzerland, Slovakia.
Initiated
Voluntary: Firm initiated
Recall number
Z-0068-2027

Completed Class II Medical devices

Recall started
5 April 2023
Reason
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malt
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1977-2023, Z-1976-2023

Completed Class II Medical devices

Recall started
3 May 2022
Reason
cybersecurity vulnerability
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austri
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1260-2022, Z-1259-2022

Completed Class II Medical devices

Recall started
22 February 2022
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.
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 Federatio
Initiated
Voluntary: Firm initiated
Recall number
Z-0854-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.