FDA-Device2023-04-05Class II

PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Entopsis , Inc.
Hazard

Presence of misleading label statements on the product label.

Sold states
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Affected count
3 units
Manufactured in
7600 Nw 69th Ave, N/A, Medley, FL, United States
Products
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2023

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