Recall Z-1954-2021— Magellan Diagnostics, Inc.

Name: FDA recall Z-1954-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-07

Class I · Terminated

Class I FDA medical device recall by Magellan Diagnostics, Inc., initiated 2021-05-07, terminated 2023-10-24. It names one FDA 510(k) clearance: K123563. Product: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098. Reason: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples..

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class I
Status: Terminated
Initiated: 2021-05-07
Terminated: 2023-10-24
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

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Reason for recall

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

Data sourced from openFDA. This site is unofficial and independent of the FDA.