Recall Z-1298-2023— Entopsis , Inc.

Name: FDA recall Z-1298-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-21

Class II · Ongoing

Class II FDA medical device recall by Entopsis , Inc., initiated 2023-02-21. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Presence of misleading label statements on the product label..

Recalling firm: Entopsis , Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-21
Firm location: Medley, FL, United States

Product description

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

Reason for recall

Presence of misleading label statements on the product label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.