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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87340

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

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Event summary

Timeline bucket
February 05, 2021
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
OraSure Technologies, Inc.

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

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

Z-1183-2021
Recall number
Z-1183-2021
Initiated
February 05, 2021
Classification
Class III
Status
Terminated
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

Code information

Lot 6681090, Exp date 2021-03. UDI: 608337000191

Distribution pattern

US Nationwide distribution in the states of KS, NJ, OH, VA.