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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81074

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

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Event summary

Timeline bucket
August 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Magellan Diagnostics, 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

Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

Z-0285-2019
Recall number
Z-0285-2019
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Quantity
1,465 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.

Code information

Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09. Exp. Date:November 10, 2019

Distribution pattern

Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.