Class I — Magellan Diagnostics, Inc.
| Recalling firm | MAGELLAN Diagnostics INC. |
|---|---|
| Registered facility | Magellan Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems |
| Product | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System. |
| Quantity | 6018 kits (total)= 5818 (US)and 200 (OUS) |
| Distribution | Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIE… |
| Initiated | 2017-05-23 |
| Classified | 2017-06-05 |
| Terminated | 2021-07-08 |
| Recall number | Z-2226-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Magellan Diagnostics, Inc. (Z-2226-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77211/
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