FDA recall Z-3004-2020

Product

PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

Reason for recall

Reagents were shipped to customers after the Use by data indicated on its labeling.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.

Key facts

Status

Terminated

Initiation date

2020-06-24

Report date

2020-09-30

Termination date

2021-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kanata, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3004-2020