Exact FDA event identifier

Event 77211

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 23, 2017
Product types: Device
Classifications: Class I
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

2 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 2

Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

Z-2225-2017

Recall number: Z-2225-2017
Initiated: May 23, 2017
Classification: Class I
Status: Terminated
Recalling firm: Magellan Diagnostics, Inc.
Quantity: 171,979 kits (total)= 153,447 (US)and 18532 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

Code information

All lot codes

Distribution pattern

Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM

device · product 2 of 2

Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

Z-2226-2017

Recall number: Z-2226-2017
Initiated: May 23, 2017
Classification: Class I
Status: Terminated
Recalling firm: Magellan Diagnostics, Inc.
Quantity: 6018 kits (total)= 5818 (US)and 200 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

Code information

All lot codes