Date Initiated by Firm |
January 09, 2018 |
Create Date |
April 03, 2018 |
Recall Status1 |
Terminated 3 on December 11, 2020 |
Recall Number |
Z-1296-2018 |
Recall Event ID |
79279 |
510(K)Number |
K142705
|
Product Classification |
Lead, atomic absorption - Product Code DOF
|
Product |
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001
Intended for the quantitative measurement of lead in a whole blood sample. |
Code Information |
Part Number: 82-0001. 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 Plus 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 |
79 |
Distribution |
Worldwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
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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 = Magellan Diagnostics
|