Copan WASP recalls PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology…
Read the official notice →- Date
- 2025-05-28
- Country
- United States
- Brand
- Copan WASP
- Product
- PhenoMATRIX
- Classification
- Class II
- Units
- US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Copan WASP recalls
- 2026-08-12
USCopan WASP recalls Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product…
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Other drugs & medical recalls in the United States
- 2025-06-04
- US
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- US
Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.,…
Failed Impurities/Degradation Specifications
- 2025-05-28
- US
Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- US
Becton Dickinson Infusion Therapy Systems, Inc. recalls BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV…
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed -…
FDA · DeviceBecton Dickinson Infusion Therapy Systems, Inc.Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX,…Official notice → - US
Echopixel, Inc. recalls TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care…
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
FDA · DeviceEchopixel, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA,…Official notice → - US
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw,…
FDA · DeviceSmith & Nephew, Inc.Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH,…Official notice →