QUIDEL ORTHO recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version:…
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Read the official notice →- Date
- 2025-01-22
- Country
- United States
- Brand
- QUIDEL ORTHO
- Product
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version:…
- Classification
- Class II
- Units
- Domestic: Nationwide Distribution International: Australia, Belgium, Bermuda,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2025-01-22
USOlympus Corporation of the Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be…
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- US
ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X…
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
FDA · Deviceev3 IncWorldwide distribution - US (& PR) Nationwide and the countries of Chile,…Official notice → - US
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier…
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is…
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography,…
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices)…
- US
Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- US
Intuitive Surgical, Inc. recalls 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA · DeviceIntuitive Surgical, Inc.U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado,…Official notice →