DNA Genotek PrepIT Q2A Kit Recalled for Expired Reagents
DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit, Model PT-Q2A-96, containing component reagents AG and ST. The recall involves Lot PT-Q2A WE11. This product is used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
The recall was initiated because the reagents were shipped to customers after the 'Use by' date indicated on the labeling. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected products were distributed worldwide, including in the United States (specifically CA, MA, MD, MN, NY, PA, and TX) and China. Users should stop using the product and contact DNA Genotek Inc. for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- DNA Genotek Inc.
- Hazard
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot PT-Q2A WE11
Distribution
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