FDA Warning Letter

FDA sounds bacteria alarms over CGMP violations in Maine
By Liz Carey
Tom's troubles highlight the importance of being inspection-ready.
November 21, 2024
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FDA warns against use of Cue Health’s COVID-19 tests due to risk of false results
By LabPulse.com staff writers
Approximately 248,109 kits were distributed nationwide in the U.S.
October 17, 2024
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FDA issues warning for Cue Health COVID-19 tests
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings due to an increased risk of false results.
May 14, 2024
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FDA tells consumers to trash tests from company involved in illicit lab scandal
By Nick Paul Taylor
The FDA is unable to confirm how well the tests perform and, as such, there are concerns that the products may not be safe and effective.
August 16, 2023
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Co-Diagnostics penalized by SEC for COVID-19 test claims, failing to disclose hiring of relatives
By LabPulse.com staff writers
The SEC has filed a cease-and-desist order and fined Co-Diagnostics $250,000 due to allegations that the firm filed misleading press releases about its COVID-19 tests and not disclosing financial transactions involving the family members of executives.
July 10, 2023
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Stop using certain SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics, FDA says
By LabPulse.com staff writers
The FDA said in a warning notice published at its website on Thursday that it has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit.
May 5, 2023
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FDA warns of shortage of blood sample collection tubes
By LabPulse.com staff writers
The FDA said that the U.S. has been "experiencing significant interruptions" in the supply of blood-draw tubes during the COVID-19 public health emergency. The agency in June 2021 issued a letter to labs and healthcare facilities warning of a shortage of sodium citrate blood specimen collection (light blue top) tubes.
January 18, 2022
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FDA puts kibosh on use of Innova Medical coronavirus test
By Brian Casey
In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
June 9, 2021
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FDA ups its game in oversight of pharmacogenetic tests
By Emily Hayes
In a statement on February 20, the agency explained that its Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) are collaborating on the monitoring and review of evidence supporting pharmacogenetic (PGx) tests, which are used to match medications to patients based on genetic profiling.
February 19, 2020
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ACLA blasts FDA's 'troubling actions' on pharmacogenetic tests
By Emily Hayes
ACLA President Julie Khani spelled out the association's concerns and requested a meeting in a September 18 letter to FDA Acting Commissioner Dr. Ned Sharpless; Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health; and Dr. Timothy Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health.
September 18, 2019
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AMP spells out how labs should report genetic test results
By Emily Hayes
The AMP endorsed the use of evidence-based guidelines for pharmacogenomic tests in clinical practice from the international Clinical Pharmacogenetics Implementation Consortium (CPIC). Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA), the AMP noted.
September 3, 2019
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Myriad's GeneSight woes reflect closer FDA oversight
By LabPulse.com staff writers
The company's stock plunged by 42.76% on August 14, to a close of $25.50. In its report for its fiscal fourth quarter (end-June 30), Myriad reported sales of $29.8 million for GeneSight, down by 12% from the same period in 2018. For all molecular diagnostic products, the company reported quarterly sales of $196.9 million, up 9% from the same period in 2018.
August 13, 2019
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