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LeadCare® II Blood Lead Analyzer Kit, Refurbished

by Magellan Diagnostics, Inc. United States GUDID

Product code DOF

Regulatory status

as of 24 Oct 2026

Recall ongoing. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850355006178 UDI-DIDate20 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

13 recalls · 6 ongoing · FDA

    • 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.

Specification

GUDID · synced 8 Jun 2026

Generic Name
Lead (Pb) analyser IVD
Model / Ref / Catalog
LeadCare® II, 70-65829R
Primary DI / UDI-DI
00850355006178
510(k) Number
FDA Product Code
DOF
GMDN Term
Lead (Pb) analyser IVD
Device Class
Class II
Regulation Number
862.3550
Commercial Distribution
In Commercial Distribution

Related devices

Category: Lead (Pb) analyser IVD

Cleared under the same submission (K052549)

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI bd7c22a6-d45b-4fd4-95d4-ebc2dc557837 37 fields · synced 8 Jun 2026