Z-2225-2017Class I

Magellan Diagnostics LeadCare and LeadCare II test Kits

Name: Z-2225-2017 Magellan Diagnostics LeadCare and LeadCare II test Kits
Creator: Magellan Diagnostics, Inc.
Published: 2017-05-23
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2017-05-23 / Terminated / root cause: design

FDA source

Magellan Diagnostics, Inc. began a recall of 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... on 2017-05-23. FDA classified it as Class I and gives the reason as "Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems". 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-2225-2017
Classification: Class I
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-06-05
Terminated: 2021-07-08
Recalling firm: Magellan Diagnostics, Inc.
Product: 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.
Product code: DOF Lead, Atomic Absorption
Reason for recall: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Root cause tag: design
FDA root cause: Device Design
Action: Magellan issued a Safety Notification letter from May 23-25, 2017 . The firm states following the FDA Safety Notice, published May 17, 2017, this notification is to advise your facility regarding a change to existing LeadCare product usage and labeling. Prior instructions for use included capillary and venous blood samples. However, because the LeadCare Testing Systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples, the FDA recommends discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus). Capillary samples may still be used on all LeadCare prducts listed above. Users requested to complete/sign Fax Form Record to verify that you have read and understood the Safety Communication to Customers on page 1. Contact Reba Daoust, Director of QA/RA 978-248-4811 or [email protected]
Quantity in commerce: 171,979 kits (total)= 153,447 (US)and 18532 (OUS)
Distribution: 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
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2225-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2225-2017	Class I	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-05
Z-2226-2017	Class I	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-05

Product code DOF

K971640Class IILeadcare Blood Lead Testing SystemEsa, Inc. / cleared 1997-09-09

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)