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Recall Observatory FDA recall evidence

Device product

PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

Z-1300-2023

February 21, 2023

Class II

Product summary

Firm
Entopsis , Inc.
Event
Event 91723
Status
Ongoing
Classification
Class II
Quantity
97 units
Official record key
device-enforcement:Z-1300-2023

Official wording

Reason: Presence of misleading label statements on the product label.

Code information: a) REF 78378001, Lot Numbers: 4, Exp. 02/2023; 7, Exp. 07/2023; b) REF 78378025, Lot Numbers: 6, Exp. 06/2023; c) REF 78378100, Lot Numbers: 7, Exp. 07/2023

Distribution pattern: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of misleading label statements on the product label.