LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only — Class II medical device recall Z-0219-2024
Ongoing recall by Magellan Diagnostics, Inc., reported 2023-11-15, distributed nationwide. During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes w
| Recall number | Z-0219-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2023-09-19 |
| Classified | 2023-11-03 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 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 and 35 more |
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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0219-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.