FDAFebruary 18, 2022device
ORAcollect RNA: ORE-100
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Evaporation of stabilizing liquid reducing shelf life.
What to do
FDA enforcement status: Ongoing
Brands named
dna genotekdna
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.0252022-02-18
- FDAPrepIT 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.2020-06-24
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