FDA Device recall Z-0655-2021
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centri…
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centri… by Hardy Diagnostics, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-23 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hardy Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | UDI: (00)819398023818 Lot Number /Expiration Date 129507P /10/28/2020, 129735P /11/11/2020, 129320P /10/14/2020,…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, 460561P /10/28/2020, 459718P /10/11/2020, 461994P /11/24/2020, 462076P /11/25/2020, 466688 /2/1/2021, 459774P /10/12/2020, 460618P /10/29/2020, 461262P /11/11/2020, 461378P /11/12/2020, 462375P /11/30/2020, 461995P /11/24/2020, 460997P /11/7/2020, 464517 /12/29/2020, 460802P /11/2/2020, 459830P /10/13/2020, 460565P /10/28/2020, 460290P /10/24/2020, 461013P /11/5/2020, 464529 /12/30/2020, 460621P /10/29/2020, 459345P /10/4/2020, 460939P /11/4/2020, 458991P /9/27/2020, 460506P /10/27/ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.