Magellan Diagnostics, Inc. Recall 87992
Description: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan Diagnostics, Inc. Recall 87992 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1954-2021 |
| Event ID | 87992 |
| Event Description | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 |
| Product Type | Devices |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines. |
| Quantity | 441 kits (192 tests/kit = 84,672 tests) |
| Recall 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. |
| Device Classification | 20210707 |
| Device Code Info | Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22. |
| Center Classification Date | 20210701 |
| Recall Initiation Date | 20210507 |
| Recalling Firm | Magellan Diagnostics, Inc. |
| Initial Notification | Letter |
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