Recall Z-0219-2024 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
| Date | Nov 3, 2023 (initiated Sep 19, 2023) |
| Status | Open, Classified |
| Reason | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely el |
| Root cause | Nonconforming Material/Component |
| Action | Magellan notified distributors/end users. Distributors initially contacted 19 September 2023 and told they would receive additional contacts from Magellan related to the recall and requests for a formal response. All distributors contacted by phone and provided the Recall Response forms included in the Recall Notification Letters. Hard copy recall notification letters issued via mail on Sept. 22, 2023. Distributors requested to provide customer lists and notifications will be carried out to the user level. Distributors will be permitted to continue distribution of impacted product, and use |
| Quantity | 11,442 LeadCare II kits (549,216 tests) |
| Distribution | US Nationwide distribution. |
| 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 |