Recall Z-0655-2021— Hardy Diagnostics
Class II · Terminated
Class II FDA medical device recall by Hardy Diagnostics, initiated 2020-10-23, terminated 2022-09-20. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing..
- Recalling firm
- Hardy Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-23
- Terminated
- 2022-09-20
- Firm location
- Santa Maria, CA, United States
Product description
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
Reason for recall
There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.