Hardy Diagnostics Recalls Viral Transport Media Due to Contamination Risk
Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.
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 involves a risk-of-harm product where the hazard is the potential for compromised COVID-19 detection, but no injuries or illnesses have been reported.
Plain-English summary
Hardy Diagnostics is recalling Viral Transport Medium, 3ml, Ref: R99, due to a potential for contamination within the product. The affected devices are packaged in plastic centrifuge tubes and are used for the collection and transport of clinical specimens for the recovery of viral agents.
The recall is being issued because the use of contaminated Viral Transport Media for the transport of patient specimens may compromise the detection of COVID-19 by the final device used for testing. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recall covers 686,920 devices distributed nationwide across multiple US states and Puerto Rico. Consumers and healthcare facilities should stop using the affected lots and contact Hardy Diagnostics for further instructions.
The recalled product
- Product
- Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
- Manufacturer
- Hardy Diagnostics
- Affected units
- 686,920
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 (20)
- UDI: (00)819398023818 Lot Number /Expiration Date 129507P /10/28/2020
- 129735P /11/11/2020
- 129320P /10/14/2020
- 129932P /11/23/2020
- 130049P /11/29/2020
- 460929P /11/4/2020
- 463439P /12/14/2020
- 463986P /12/22/2020
- 459930P /10/17/2020
- 460805P /11/2/2020
- 462411P /11/30/2020
- 459717P /10/8/2020
- 463483P /12/15/2020
- 462121P /11/26/2020
- 460391P /10/25/2020
- 463782P /12/20/2020
- 461645P /11/17/2020
- 461643P /11/17/2020
- 461289P /11/11/2020
- 461381P /11/12/2020
Distribution
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