FDAClass IFebruary 23, 2022

RNAstill Molecular Transport Medium Vial recall

RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection…

Why was RNAstill Molecular Transport Medium Vial recalled?

The product does not have 510(k) clearance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.

Product
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection…
Recalling firm
BASE 10 GENETICS INC
Quantity
455,791 kits
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.
Recall date
February 23, 2022
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls