FDA Medical Device Recalls (openFDA)
Magellan Diagnostics, Inc.: 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.
- Recall number
- Z-0285-2019
- Recalling firm
- Magellan Diagnostics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-08-08
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- 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.
- Root cause
- 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
- 1,465 kits
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K052549","K971640"]
- PMA numbers
- not on file
- Product code
- DOF
- Firm FEI
- 1218996
- Firm city
- North Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28