Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data
Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific hospitalization reports or structural defects fall into the High severity category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Krishe Inc is recalling Dasky Disposable Sampling Tubes, Reference VSM02. The product includes transport media, nasal swabs, and a package insert. The recall involves 441,500 units distributed in Louisiana, Texas, Florida, and Georgia.
The recall was initiated because verification and validation of the virus transport medium tubes was not provided to the FDA prior to sale and marketing. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have these products should stop using them and contact Krishe Inc for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
- Manufacturer
- Krishe Inc
- Hazard
- Affected units
- 441,500
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)
- All Lots
Distribution
Part of a larger recall action
This product is one of 4 recalled by Krishe Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Krishe Inc
See all →- HighKrishe Disposable Sampling Tubes Recalled for Missing Verification Data
FDA (Devices) · 2021-04-21
- ModerateKrishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data
FDA (Devices) · 2021-04-21
- HighKrishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data
FDA (Devices) · 2021-04-21