LumiraDx recalls LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are…
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017,…
Read the official notice →- Date
- 2022-11-02
- Country
- United States
- Brand
- LumiraDx
- Product
- LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are…
- Classification
- Class III
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 LumiraDx recalls
- 2023-06-21
USLumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of…
- 2022-07-27
- US
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
FDA · DeviceLumiraDxDomestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.Official notice →
Other drugs & medical recalls in the United States
- 2022-11-02
- US
Wright Medical Technology, Inc. recalls Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
The tibial tray lock detail is oversized (larger than specification).
FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the state of New York.Official notice → - US
Merit Medical Systems, Inc. recalls CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A,…
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient…
FDA · DeviceMerit Medical Systems, Inc.Worldwide distribution - US National distribution including in the states of…Official notice → - US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Due to manufacturing records (Release Test Results) indicating "Failed".
FDA · DeviceW L Gore & Associates, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - US
Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
FDA · DeviceLuminex CorporationDistribution US nationwide, Indonesia, and Hong Kong.Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…
FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice → - US
Angiodynamics, Inc. recalls Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement…
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, CA, DC, IN, PA.Official notice →