FDA MedWatch - RNAstill MTM Specimen Collection Kits by BASE10 Genetics:

Class I Recall - May Give False Results, and Require Special Training for Safe Handling

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: RNAstill MTM Specimen Collection Kits by BASE10 Genetics: Class I Recall - May Give False Results and Require Special Training for Safe Handling  AUDIENCE: Consumer, Patient, Health Professional ISSUE: BASE10 Genetics is recalling the RNAstill MTM specimen collection kits because they were distributed without proper premarket clearance from the FDA —meaning there is not adequate data available about this product to know how well it inactivates and stabilizes a virus for transport and storage. If the specimen collected is not properly inactivated and stabilized by the transport medium, there are two concerns: If the sample deteriorates, it could lead to false negative test results If the virus isn't inactivated prior to testing, it is possible that the virus could spread to people in the lab. These products were distributed to nursing homes, assisted living facilities, and memory facilities whose residents are at high risk of severe illness and death from COVID-19. A false negative test result could lead to a patient not receiving the care they need. Additionally, the transport medium of this specimen collection kit contains a hazardous chemical that requires special training for safe handling. It is not certain that staff at long term care facilities where the product was distributed are trained to safely handle this hazardous chemical. As a result of all these issues, use of the affected product could cause serious adverse health consequences and death. There have been no reports of injuries, adverse health consequences or death associated with the use of this product. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: BASE10 Genetics RNAstill MTM specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal (deep inside the nose to the back of the throat) or oropharyngeal (just beyond the mouth into the throat) swab samples from patients, without needing dry ice, refrigeration, or special containment. RECOMMENDATIONS: On January 10, 2022, BASE10 Genetics sent "URGENT: REAL BIOTECH CORPORATION RNAstill MTM RECALL" letters to all affected customers with the following instructions:  Discontinue use. Return all unused product. Complete and return Acknowledgement and Receipt Form. The FDA is also recommending the following precautions when handling the recalled product: Do not allow the MTM to come into contact with bleach or other oxidizing agents, acidic or alkaline products to prevent the release of toxic gases. Return unused product to BASE10 Genetics as requested in the recall letter. Do not dispose of any unused product yourself. For additional information, please see the FDA's Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laboratory Staff and Health Care Providers | FDA Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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