FDA recall Z-1300-2023

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

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-1300-2023