Reported Dec 3, 2025 · Ongoing
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.…
Magellan Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Magellan Diagnostics, Inc. · 101 Billerica Ave Bldg 4 · North Billerica, MA · 01862-1271
Is this the product you have?
- 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)
- Lot codes and dates
- Product NameLeadCare¿ II Blood Lead Test Kit
- Catalog Number70-6762
- Impacted Lot/Sublot Numbers
2333M2333M-012333M-022333M-032333M-042333M-052333M-062333M-072333M-082333M-092333M-102333M-11
- Device Identifier(01)00850355006000
- Amount recalled
- 1,774 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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