RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAsti
Summary
The FDA issued a Class I for RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of by BASE 10 GENETICS INC. Reason: The product does not have 510(k) clearance..
Details
Source
Device Recall
External ID
Z-0568-2022
Action Date
2022-02-23
Status
Terminated
Category
device
Product Description
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.
Lot/Code Info: Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.
Quantity Affected: 455,791 kits
Reason for Recall
The product does not have 510(k) clearance.
Distribution
US Nationwide distribution in the states of AL, CO, FL, GA, ID, IN, KY, MD, NC, NV, NY, OH, OR, TN, UT, VA, WA, and WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-10
Company
Chicago, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BASE 10 GENETICS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BASE 10 GENETICS INC have FDA actions?
This is the only FDA action we have on record for BASE 10 GENETICS INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0568-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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