FDA recall Z-1298-2023

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 for recall

Presence of misleading label statements on the product label.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-02-21

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medley, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1298-2023