FDAFDA · Food and drugs·Recall number Z-3004-2020
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.
Published September 30, 2020 · Recall initiated: June 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reagents were shipped to customers after the Use by data indicated on its labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DNA Genotek Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
- Lot
- Lot PT-Q2A WE11
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Canada
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