Recall Z-3004-2020— DNA Genotek Inc.
Class III · Terminated
Class III FDA medical device recall by DNA Genotek Inc., initiated 2020-06-24, terminated 2021-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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: Reagents were shipped to customers after the Use by data indicated on its labeling..
- Recalling firm
- DNA Genotek Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-06-24
- Terminated
- 2021-11-01
- Firm location
- Kanata, N/A, Canada
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.