Recall Z-0285-2019 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 k
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH. |
| Root cause | Process control |
| Action | The firm, Magellan, notified the Customers (end users) by telephone or email on August 8, 2018 to provide notification of the deficiency of the LeadCare II Blood Lead Test Kit having Lot Number 1808M. Replacement Buttons and an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 9 2018 ( were shipped on August 9, 2018, for delivery on Friday, August 10, 2018.) The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Do NOT use the Yellow calibration button marked 1808M. 2. Discard the Yellow calibration button that came with t |
| Quantity | 1,465 kits |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa. |
| FDA record | Open on fda.gov |