Recall Z-1954-2021 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
| Date | Jul 1, 2021 (initiated May 7, 2021) |
| Status | Terminated |
| Reason | Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples. |
| Root cause | Nonconforming Material/Component |
| Action | On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending |
| Quantity | 441 kits (192 tests/kit = 84,672 tests) |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM Magellan Diagnostics, Aug 20, 2013 |