Z-1925-2017Class I

Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

Name: Z-1925-2017 Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Creator: Magellan Diagnostics, Inc.
Published: 2014-11-29
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2014-11-29 / Terminated / root cause: design

FDA source

Magellan Diagnostics, Inc. began a recall of Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 on 2014-11-29. FDA classified it as Class I and gives the reason as "LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan...". 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-1925-2017
Classification: Class I
Status: Terminated
Initiated: 2014-11-29
Posted: 2017-05-18
Terminated: 2022-02-26
Recalling firm: Magellan Diagnostics, Inc.
Product: Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Product code: DOF Lead, Atomic Absorption
Reason for recall: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Root cause tag: design
FDA root cause: Device Design
Action: Magellan issued a follow-on Recall notification related to the FDA Safety Notification dated May 17, 2017. This current recall follows FDAs recommendation to remove venous blood samples as an allowable sample type from all LeadCare products. This recall will supersede and replace the prior Recall notifications. Notifications issued by : UPS Letter (US), Registered Letter, E-mail, or Phone calls form May 23-May 25. Questions: Reba Daoust, Director of QA/RA 978-248-4811 or [email protected] Refer to Firm's website: http://www.leadcare2.com/getmedia/2fd8a90f-5c64-4058-b6ab-5db13512f0fe/Letter-to-our-customers-5-17-17.pdf.aspx. The notification of May 2017 supercedes the firms previous communications:. Magellan Diagnostics, notified customers by letter dated Nov 29, 2014 and provided with the problem, mitigation action( customers have been advised to implement a minimum 24-hour incubation of the blood-treatment reagent mixture prior to analysis) . Customers were instructed to return a completed FaxBack form via fax to 978-600-1480. A revised letter issued May 1, 2017 recommending that customers make the following workflow changes: 1. Discontinue collecting blood samples for lead testing in Becton Dickinson (BD) EDTA Vacutainer tubes: Lavender and Tan tops. 2. Discontinue the 24 hour incubation for sample preparation. On 5/17/17 FDA issued News Release - FDA warns Americans about risk of inaccurate results from certain lead tests- manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults. Blood drawn from a vein may provide results that are lower than the actual level in the blood. FDA is warning laboratories not to use Magellan Diagnostic lead tests wit blood drawn from the vein. At this time all Leadcare systems can be used with blood drawn from a finger or heel stick. Based on FDA/s warning the firm issued notification letter to users on 5/xx/17.
Quantity in commerce: 49 units
Distribution: Nationwide Distribution
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-1926-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-17

Product code DOF

K123563Class IILeadcare (R) Ultra (Tm) Blood Lead Testing SystemMagellan Diagnostics / cleared 2013-08-20

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)