Recall Z-1926-2017— Magellan Diagnostics, Inc.
Class I · Terminated
Class I FDA medical device recall by Magellan Diagnostics, Inc., initiated 2014-11-29, terminated 2022-02-26. It names one FDA 510(k) clearance: K142705. Product: Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010. Reason: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system..
- Recalling firm
- Magellan Diagnostics, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-11-29
- Terminated
- 2022-02-26
- Firm location
- North Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reason for recall
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.