Recall Z-1925-2017— Magellan Diagnostics, Inc.

Name: FDA recall Z-1925-2017
Creator: U.S. Food and Drug Administration
Published: 2014-11-29

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: K123563. Product: Magellan Diagnostics LeadCare Ultra Blood Analyzer 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 record

K123563 — LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEMMagellan Diagnostics·cleared 2013-08-20

K-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 Analyzer 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.