Z-0285-2019Class II

Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood...

Name: Z-0285-2019 Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood...
Creator: Magellan Diagnostics, Inc.
Published: 2018-08-08
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2018-08-08 / Terminated / root cause: manufacturing process

FDA source

Magellan Diagnostics, Inc. began a recall of 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... on 2018-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0285-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Posted: 2018-10-26
Terminated: 2020-05-12
Recalling firm: Magellan Diagnostics, Inc.
Product: 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.
Product code: DOF Lead, Atomic Absorption
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Magellan, notified the Customers (end users) by telephone or email on August 8, 2018 to provide notification of the deficiency of the LeadCare II Blood Lead Test Kit having Lot Number 1808M. Replacement Buttons and an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 9 2018 ( were shipped on August 9, 2018, for delivery on Friday, August 10, 2018.) The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Do NOT use the Yellow calibration button marked 1808M. 2. Discard the Yellow calibration button that came with the LeadCare II Test Kit Lot 1808M. 3. Place the new Blue calibration button with the test kit and use for controls and patient testing with Lot 1808M. 4. Inform your staff of the calibration button exchange. 5. Complete the fax form record included with this letter and fax to 978-600-1480 or email a scanned copy of the completed form to [email protected]. If you have questions, please contact us at 800-275-0102 or [email protected].
Quantity in commerce: 1,465 kits
Distribution: Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0285-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0285-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-26

Product code DOF

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)