FDA warning letter

Meridian LeadCare Business Undergoes FDA Inspection, Product Recall

The firm's Magellan business originally received a warning letter from the agency in 2017 regarding failure to submit medical device reports.

FDA Tells Testing Firm to Stop Sale of Unauthorized COVID-19 At-Home Kit

The FDA said that Anytime COVID is marketing a test for at-home use that has not received premarket approval or investigation device exemption.

FDA Warns of Potential False Positive Results With Roche Cobas Liat Rapid SARS-CoV-2, Flu Test

The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes.

FDA Warns Lab Company to Stop Sale of Unauthorized SARS-CoV-2 Collection Kit

The company is currently selling an at-home sample collection kit that hasn't received premarket approval or investigational device exemption from the agency.

FDA Sends Warning Letters About Unauthorized SARS-CoV-2 Tests

The FDA letters were sent to two firms advertising an antibody home test being sold on two websites and a stool test for SARS-CoV-2.

Jul 7, 2020

FDA Letter Warns About False-Positive Results From Becton Dickinson SARS-CoV-2 Test

Jun 30, 2020

FDA Issues Warning Letter to Luminex

Jun 29, 2020

KBMO Dx Receives FDA Warning About Unauthorized At-Home Collection for Coronavirus Testing

Jun 17, 2020

FDA Warns Firms About Improper Sale of SARS-CoV-2 Antibody Tests

Nov 20, 2019

FDA Warns Carolina Liquid Chemistries About Improper Use of Reagent Kits

Oct 7, 2019

HTG Molecular Warned by Nasdaq of Listing Non-Compliance

Sep 19, 2019

ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves

Aug 2, 2019

FDA Issues Notice on Qiagen Recall of QiaSymphony MDx Platform Filter Tips

Apr 15, 2019

Inova Decides to End PGx Test Offerings in Response to FDA Warning Letter

Apr 10, 2019