Z-3035-2017Class II

LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls

Name: Z-3035-2017 LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls
Creator: Magellan Diagnostics, Inc.
Published: 2016-01-20
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2016-01-20 / Terminated / root cause: design

FDA source

Magellan Diagnostics, Inc. began a recall of LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of... on 2016-01-20. FDA classified it as Class II and gives the reason as "LeadCare II Test Kits controls out of range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3035-2017
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Posted: 2017-08-15
Terminated: 2018-02-21
Recalling firm: Magellan Diagnostics, Inc.
Product: LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Product code: DOF Lead, Atomic Absorption
Reason for recall: LeadCare II Test Kits controls out of range
Root cause tag: design
FDA root cause: Device Design
Action: Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..
Quantity in commerce: 12,931 kits
Distribution: Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
Product codes and lots: Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3035-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3035-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-15

Product code DOF

K052549Class IILeadcare II Blood Lead Testing SystemEsa Biosciences, Inc. / cleared 2005-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)