FDA-Device2023-04-05Class II
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; 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
94 units
Manufactured in
7600 Nw 69th Ave, N/A, Medley, FL, United States
Products
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2023Don't want to check this manually?
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