FDA recall Z-0655-2021

Hardy Diagnostics · Class II · device

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.

Distribution

US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.

Key facts

Status
Terminated
Initiation date
2020-10-23
Report date
2020-12-30
Termination date
2022-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2021