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Recall Observatory FDA recall evidence

Device 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.

Z-3004-2020

June 24, 2020

Class III

Product summary

Firm
DNA Genotek Inc.
Event
Event 86279
Status
Terminated
Classification
Class III
Quantity
74
Official record key
device-enforcement:Z-3004-2020

Official wording

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

Code information: Lot PT-Q2A WE11

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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