Recall archive / FDA device enforcement
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of... — FDA record Z-0219-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
- Reason
- During an internal audit a small percentage (
- Classification
- Class II
- Recalling firm
- Magellan Diagnostics, Inc.
- Quantity
- 11,442 LeadCare II kits (549,216 tests)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0219-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI :(01)00850355006000 Lot Numbers: 2231 2231-10 2303M-11 2303M-12 2303M-13 2303M-15 2305M-01 2305M-02 2305M-03 2305M-04 2305M-05 2306M-01 2306M-02 2306M-03 2306M-04 2306M-05 2306M-06 2307M 2307M-04 2307M-05 2307M-06 2307M-07 2307M-10 2307M-11 2308M-01 2308M-02 2308M-03 2308M-07 2309M 2310M-01 2310M-03 2310M-04 2310M-05 2310M-06 2310M-08 2311M-02 2311M-03 2311M-05 2311M-09 2311M-10 2312M 2312M-01 2312M-04 2312M-05 2312M-07 2313M 2313M-01 2313M-05 2313M-07 2314M-06 2314M-07 2314M-08 2314M-09 2314M-12 2314M-13 2315M-02 2315M-03 2315M-04 2315M-05 2315M-06 2315M-07 2315M-08 2315M-13 2316M 2316M-03 2316M-04 2316M-05 2316M-06 2316M-11 2316M-12 2317M 2317M-01 2318M 2320M-06 7308M |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Sep 19, 2023
- Center classification date
- Nov 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.