Recall Z-1895-2026 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
| Date | Apr 17, 2026 (initiated Mar 13, 2026) |
| Status | Open, Classified |
| Reason | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing. |
| Root cause | Device Design |
| Action | On March 13, 2026, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. REQUIRED ACTIONS: This field action does NOT require removal of product from the field. The LeadCare Test Systems continue to perform as intended when used according to the product labeling and Instructions for Use. The regulatory status of all products noted above remains unchanged and the product supply uninterrupted. Technical and customer support will continue as normal. LEADCARE II: The only blood collection devices validated for use with the Magellan LeadCare II Blood Lead Test Kit are the capillary tubes |
| Quantity | 284 |
| Distribution | Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, Sou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM Esa Biosciences, Inc., Oct 6, 2005 |