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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86607

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Thomas Scientific

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

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

Z-0449-2021
Recall number
Z-0449-2021
Initiated
July 14, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Thomas Scientific
Quantity
115,800 cs (100 vials/cs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

Code information

Lots 060620MB1 061420MB2 062120MB1 062220MB2 060620MB2 052220MB1 051820D01 060120D01 061520MA1 062220D02 061720MB1 052720D02 061920E01 052120E01

Distribution pattern

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Field note

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