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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81220

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

Open FDA event record

Event summary

Timeline bucket
September 14, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Luminex Corporation

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

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

Z-0445-2019
Recall number
Z-0445-2019
Initiated
September 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
Luminex Corporation
Quantity
12,700 trays

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential to lead to a false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential to lead to a false negative results.

Code information

Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B

Distribution pattern

Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France