Viral Transport Medium — Class II medical device recall Z-0655-2021
Terminated recall by Hardy Diagnostics, reported 2020-12-30, distributed nationwide. There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media
| Recall number | Z-0655-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-12-21 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2022-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 686,920 devices |
| UPC / GTIN / UDI-DI | 00819398023818 |
| Lot numbers | 129320P, 129507P, 129735P, 129932P, 130049P, 458991P, 459345P, 459717P, 459718P, 459774P, 459830P, 459930P, 460290P, 460391P, 460433P, 460506P, 460561P, 460565P, 460618P, 460621P, 460802P, 460805P, 460929P, 460939P, 460954P, 460997P, 461013P, 461262P, 461289P, 461362P, 461378P, 461381P, 461643P, 461645P, 461832P, 461994P, 461995P, 462076P, 462121P, 462375P and 9 more |
| Model numbers | R99 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0655-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.