Recall Z-1295-2018— Magellan Diagnostics, Inc.

Name: FDA recall Z-1295-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-09

Class II · Terminated

Class II FDA medical device recall by Magellan Diagnostics, Inc., initiated 2018-01-09, terminated 2020-12-11. It names one FDA 510(k) clearance: K052549. Product: LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.. Reason: The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot..

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-09
Terminated: 2020-12-11
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·cleared 2005-10-06

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 II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

Reason for recall

The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

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