Reported Dec 30, 2020 · Terminated
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is…
Hardy Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hardy Diagnostics · 1430 W McCoy Ln · Santa Maria, CA · 93455-1005
Is this the product you have?
- Viral Transport Medium, 3ml
- RefR99
- Container typeTube
- Packaged20 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
- Lot codes and dates
- 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 /10/27/2020, 460954P /11/5/2020, 461362P /11/12/2020, 461832P /11/22/2020, 462511P /12/1/2020, 460433P /10/26/2020
- Amount recalled
- 686,920 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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