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…
Read the official notice →- Date
- 2025-12-10
- Country
- United States
- Brand
- Illumina
- Product
- Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD,…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of PA, NJ, CA, NC, UT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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 →- 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 → - 2022-04-06
- US
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…
FDA · DeviceIllumina, Inc.US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-17
- US
Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- US
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals,…
Failed stability specifications: Out of specification for hardness test
- 2025-12-11
- US
Uuoeebb Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violate Mandatory Standard for Infant Walkers; Sold on Amazon…
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant…
- 2025-12-10
- US
Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
FDA · DevicePhilips Ultrasound, LLCWorldwide US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood…
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of OH, IL, NY,…Official notice →