Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LeadCare II Blood Lead Test Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall LeadCare II Blood Lead Test Kit see related information
Date Initiated by Firm August 08, 2018
Create Date October 26, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-0285-2019
Recall Event ID 81074
510(K)Number K052549  K971640  
Product Classification Lead, atomic absorption - Product Code DOF
Product Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood.
Catalog Number: 70-6762
Primary DI No:
00850355006000

The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
Code Information Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09.  Exp. Date:November 10, 2019
Recalling Firm/
Manufacturer		 Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information Contact SAME
978-248-4811
Manufacturer Reason
for Recall		 Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
FDA Determined
Cause 2		 Process control
Action The firm, Magellan, notified the Customers (end users) by telephone or email on August 8, 2018 to provide notification of the deficiency of the LeadCare II Blood Lead Test Kit having Lot Number 1808M. Replacement Buttons and an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 9 2018 ( were shipped on August 9, 2018, for delivery on Friday, August 10, 2018.) The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Do NOT use the Yellow calibration button marked 1808M. 2. Discard the Yellow calibration button that came with the LeadCare II Test Kit Lot 1808M. 3. Place the new Blue calibration button with the test kit and use for controls and patient testing with Lot 1808M. 4. Inform your staff of the calibration button exchange. 5. Complete the fax form record included with this letter and fax to 978-600-1480 or email a scanned copy of the completed form to reply@magellandx.com. If you have questions, please contact us at 800-275-0102 or LeadCareSupport@magellandx.com.
Quantity in Commerce 1,465 kits
Distribution Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
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.
510(K)s with Product Code = DOF and Original Applicant = ESA, INC.
-
-