Krishe Disposable Sampling Tubes Recalled for Missing Verification Data
Krishe Inc is recalling 1.7 million 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is the lack of verification data for the transport medium, which is a risk-of-harm product issue where specific injuries have not yet been reported.
Plain-English summary
Krishe Inc is recalling 1,700,000 units of Disposable Sampling Tubes, Reference VSM01. The product includes transport media, nasal swabs, and a package insert, and is classified as an In Vitro Diagnostic (IVD) device with CE marking. The recall is designated as Class II by the FDA.
The recall was initiated because verification and validation of the virus transport medium tubes was not provided to the FDA prior to the sale and marketing of the product. This lack of documentation means the safety and performance of the transport medium have not been formally verified by the agency.
The affected units were distributed in the United States to the states of Louisiana, Texas, Florida, and Georgia. All lots are included in this recall. Consumers and healthcare providers should stop using these sampling tubes and contact Krishe Inc for further instructions or a refund.
The recalled product
- Product
- Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
- Manufacturer
- Krishe Inc
- Affected units
- 1,700,000
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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