LeadCare II Blood Lead Test Kit — Class II medical device recall Z-3035-2017
Terminated recall by Magellan Diagnostics, Inc., reported 2017-08-23, distributed nationwide. LeadCare II Test Kits controls out of range
| Recall number | Z-3035-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2016-01-20 |
| Classified | 2017-08-15 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2018-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CO, DE, ES, IN, KR, NZ, TH, ZA |
| Quantity | 12,931 kits |
| Lot numbers | 1507N, 1508N, 1510N, 1511M, 1511N, 1512M |
| Expiration dates | 2017-01-27, 2017-02-27, 2017-04-19, 2017-05-03, 2017-05-17, 2017-06-02 |
Product
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Reason for recall
LeadCare II Test Kits controls out of range
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-3035-2017. 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.