Recall Z-1597-2022 ยท DOF Lead, Atomic Absorption
Mckesson Medical-Surgical Inc. Corporate Office
MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
| Date | Aug 26, 2022 (initiated May 25, 2022) |
| Status | Open, Classified |
| Reason | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
| Root cause | Environmental control |
| Action | Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to pr |
| Quantity | 81 kits |
| Distribution | US Nationwide |
| 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 |