Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1298-2023 — 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

U.S. FDA — Device Enforcement · United States · 2023-02-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1298-2023
Date of alert
2023-02-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Entopsis , Inc.
Product category
device
Product type
Devices
Reported risk: Presence of misleading label statements on the product label.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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