Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
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…
Read the official notice →- Date
- 2022-04-06
- Country
- United States
- Brand
- Illumina
- Product
- Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- Classification
- Class II
- Units
- US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Illumina recalls
- 2026-10-07
USIllumina, Inc. recalls NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
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.
FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT,…Official notice →- 2025-12-10
- US
Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD,…
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…
FDA · DeviceIllumina, Inc.Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT,…Official notice → - 2023-06-28
- US
Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
FDA · DeviceIllumina, Inc.Worldwide distribution - US Nationwide and the countries of Algeria, AU…Official notice → - 2022-06-22
- US
Illumina, Inc. recalls illumina Model NextSeq 550 Dx REF 20005715
cybersecurity vulnerability
FDA · DeviceIllumina, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-13
- US
The Ritedose Corporation recalls 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A…
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
- US
Vitae Enim Vitae Scientific, Inc. recalls TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for…
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- 2022-04-06
- US
Medtronic MiniMed recalls MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781,…
New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do…
FDA · DeviceMedtronic MiniMedUS: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ,…Official notice → - US
Wright Medical Technology, Inc. recalls EasyFuse Dynamic Compression System Instrument Pack
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
FDA · DeviceWright Medical Technology, Inc.US distribution to Florida, North Carolina, Ohio, and TexasOfficial notice → - US
Human Care USA, Inc. recalls Hanger-Bar 2P 45cm
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential…
FDA · DeviceHuman Care USA, Inc.U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA,…Official notice → - US
RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2…
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
FDA · DeviceRaySearch America IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE,…Official notice →