Recall Z-3035-2017 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this re
| Date | Aug 15, 2017 (initiated Jan 20, 2016) |
| Status | Terminated |
| Reason | LeadCare II Test Kits controls out of range |
| Root cause | Device Design |
| Action | Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix.. |
| Quantity | 12,931 kits |
| Distribution | Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA |
| 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 |