BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: RNAstill MTM specimen collection kits
- Product Codes: See Recall Database Entry
- Distribution Dates: September 16, 2020 to December 1, 2021
- Devices Recalled in the U.S.: 455,791
- Date Initiated by Firm: January 10, 2022
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. They can be used to collect and store patient samples that need to be tested for viruses including SARS-CoV-2 (the virus that causes COVID-19) and other coronaviruses, influenza (flu), or adenoviruses (viruses that typically cause the common cold). They can also be used for patient samples that need to be tested for bacteria that commonly cause infections including Mycoplasma pneumoniae, Chlamydia pneumoniae, Streptococcus pneumoniae, and Streptococcus pyogenes.
Reason for Recall
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.
Who May be Affected
- Health care personnel who used the BASE10 Genetics RNAstill MTM specimen collection kits to collect and store specimen samples from patients.
- People whose test samples were collected and stored in RNAstill MTM specimen collection kits.
What to Do
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
Customers with questions or concerns about this recall may contact BASE10 Genetics at
email@example.com or call 1-866-710-1018.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.