Z-1295-2018Class II

LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro...

Name: Z-1295-2018 LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro...
Creator: Magellan Diagnostics, Inc.
Published: 2018-01-09
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2018-01-09 / Terminated / root cause: design

FDA source

Magellan Diagnostics, Inc. began a recall of LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only on 2018-01-09. FDA classified it as Class II and gives the reason as "The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot". 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-1295-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-09
Posted: 2018-04-03
Terminated: 2020-12-11
Recalling firm: Magellan Diagnostics, Inc.
Product: LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Product code: DOF Lead, Atomic Absorption
Reason for recall: The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or [email protected].
Quantity in commerce: 6,143
Distribution: Worldwide Distribution
Product codes and lots: Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03
Z-1296-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

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)