Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86853

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hardy Diagnostics

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0655-2021
Recall number
Z-0655-2021
Initiated
October 23, 2020
Classification
Class II
Status
Terminated
Recalling firm
Hardy Diagnostics
Quantity
686,920 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.