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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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, Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Krishe Inc is recalling Dasky Disposable Sampling Tubes, Reference VSM03, which contain sterile 0.85% saline and nasal swabs. The recall involves 18,000 units distributed in Louisiana, Texas, Florida, and Georgia. All lots are affected.
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 that use of, or exposure to, the 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 further instructions.
The recalled product
- Product
- Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
- Manufacturer
- Krishe Inc
- Hazard
- Affected units
- 18,000
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
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