GS Biomark LLC recalls CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200…
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Read the official notice →- Date
- 2022-12-07
- Country
- United States
- Brand
- GS Biomark LLC
- Product
- CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200…
- Classification
- Class II
- Units
- U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-12-07
USCytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
- US
Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
Potential staple deployment failure and device fragment generation
FDA · DeviceIntuitive Surgical, Inc.U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…Official notice → - US
Busse Hospital Disposables, Inc. recalls Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
- US
Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only,…
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
- US
- US