LeadCare® II Replacement AC Adapter and Plug Set

• • Ongoing Z-0162-2027 FDA Not yet classified ·initiated 4 Sep 2026

  In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

• 2 recalls, same reason

  • Ongoing Z-1895-2026 FDA Class II ·initiated 13 Mar 2026
  • Ongoing Z-1893-2026 FDA Class II ·initiated 13 Mar 2026

  Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.

• • Ongoing Z-0584-2026 FDA Class II ·initiated 23 Feb 2024

  Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

• • Ongoing Z-0219-2024 FDA Class II ·initiated 19 Sep 2023

  During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

• • Ongoing Z-1597-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• • Terminated Z-1952-2021 FDA Class I ·initiated 7 May 2021

  Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

• • Terminated Z-0285-2019 FDA Class II ·initiated 8 Aug 2018

  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.

• • Terminated Z-1295-2018 FDA Class II ·initiated 9 Jan 2018

  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.

• • Terminated Z-2226-2017 FDA Class I ·initiated 23 May 2017

  Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

• • Terminated Z-3035-2017 FDA Class II ·initiated 20 Jan 2016

  LeadCare II Test Kits controls out of range

• 2 recalls, same reason

  • Terminated Z-0042-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007
  • Terminated Z-0043-2008 FDA Unclassified (pre-2012) ·initiated 20 Sep 2007

  Level 1 and Level 2 Control values were incorrectly assigned.

Generic Name

Lead (Pb) analyser IVD

Model / Ref / Catalog

LeadCare® II, 82-0001

Primary DI / UDI-DI

00850355006123

510(k) Number

K052549 ↗

FDA Product Code

DOF

GMDN Term

Lead (Pb) analyser IVD

Device Class

Class II

Regulation Number

862.3550

Commercial Distribution

In Commercial Distribution

Category: Lead (Pb) analyser IVD