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U.S. Department of Health and Human Services

Class 2 Device Recall LeadCare II Blood Lead Analyzer

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  Class 2 Device Recall LeadCare II Blood Lead Analyzer see related information
Date Initiated by Firm January 09, 2018
Create Date April 03, 2018
Recall Status1 Terminated 3 on December 11, 2020
Recall Number Z-1295-2018
Recall Event ID 79279
510(K)Number K052549  
Product Classification Lead, atomic absorption - Product Code DOF
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information Contact
978-8562339
Manufacturer 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.
FDA Determined
Cause 2		 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 LeadCareSupport@magellandx.com.
Quantity in Commerce 6,143
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DOF and Original Applicant = ESA BIOSCIENCES INC.
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