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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the issue is the lack of provided verification and validation data prior to sale, with no reported illnesses or injuries. This aligns with the rubric for moderate severity involving documentation issues or low-risk contamination where harm has not been reported.
Plain-English summary
Krishe Inc is recalling Dasky Disposable Sampling Tubes, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R. The recall involves 10,000 units distributed in the United States, specifically 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 documentation gap means the product's performance and safety were not formally verified with the agency before it reached the market.
Consumers and healthcare providers who have these products should stop using them and contact Krishe Inc for further instructions. The source text does not report any specific illnesses or injuries associated with the use of these tubes.
The recalled product
- Product
- Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
- Manufacturer
- Krishe Inc
- Affected units
- 10,000
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
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See all →- HighKrishe Disposable Sampling Tubes Recalled for Missing Verification Data
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- HighKrishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data
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