Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0568-2022 — 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 Molec

U.S. FDA — Device Enforcement · United States · 2022-01-10 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0568-2022
Date of alert: 2022-01-10
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: BASE 10 GENETICS INC
Product category: device
Product type: Devices

Reported risk: The product does not have 510(k) clearance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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