Z-1954-2021Class I

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Name: Z-1954-2021 LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Creator: Magellan Diagnostics, Inc.
Published: 2021-05-07
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2021-05-07 / Terminated / root cause: manufacturing process

FDA source

Magellan Diagnostics, Inc. began a recall of LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 on 2021-05-07. FDA classified it as Class I and gives the reason as "Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples". 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-1954-2021
Classification: Class I
Status: Terminated
Initiated: 2021-05-07
Posted: 2021-07-01
Terminated: 2023-10-24
Recalling firm: Magellan Diagnostics, Inc.
Product: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Product code: DOF Lead, Atomic Absorption
Reason for recall: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results should be shared with the patient s physician for interpretation and to determine when retesting and follow-up care are necessary. - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available). - Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory. On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue. Immediate Actions: - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Promptly complete and return the Customer Notification Form below t
Quantity in commerce: 441 kits (192 tests/kit = 84,672 tests)
Distribution: Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Product codes and lots: Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2021	Class I	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01
Z-1953-2021	Class I	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01
Z-1954-2021	Class I	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01

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)