Home / Recalls / Medical Devices
Entopsis , Inc. recalls PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological sam
Recalled April 5, 2023 · FDA recall Z-1297-2023 · Entopsis
Hazard
Presence of misleading label statements on the product label. · FDA Class II
Units
52 units
Sold at
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Description
Presence of misleading label statements on the product label.
Product
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Manufacturer(s)
Entopsis , Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →