CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
The LeadCare¿ II Blood Lead Test System relies recalled
Magellan Diagnostics is recalling The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor, distributed nationwide in the US. The recall was initiated on 23 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0584-2026
- FDA event ID
- 97858
- Recalling firm
- Magellan Diagnostics, North Billerica, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Feb 2024
- FDA classified
- 21 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Feb 2024 | Recall initiated by company | |
| 21 Nov 2025 | Classified by FDA | +637 days |
| 3 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Magellan Diagnostics
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | (2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
| Device | CLASS II | LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
| Device | CLASS II | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only recalled | Magellan Diagnostics | Foreign Material | Nationwide |
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