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Recall Observatory FDA recall evidence

Device product

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

Z-1298-2023

February 21, 2023

Class II

Product summary

Firm
Entopsis , Inc.
Event
Event 91723
Status
Ongoing
Classification
Class II
Quantity
363 units
Official record key
device-enforcement:Z-1298-2023

Official wording

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

Code information: a) REF 597000, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 6024; b) REF 597825, Lot Numbers: 5, Exp. 06/2024; c) REF 597850, Lot Numbers: 2, Exp. 05/2024; d) REF 5970025, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 06/2024; 4, Exp. 06/2024; 5, Exp. 06/2024; e) REF 5971000, Lot Numbers: 4, Exp. 06/2024

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.