Recall Z-3035-2017— Magellan Diagnostics, Inc.

Name: FDA recall Z-3035-2017
Creator: U.S. Food and Drug Administration
Published: 2016-01-20

Class II · Terminated

Class II FDA medical device recall by Magellan Diagnostics, Inc., initiated 2016-01-20, terminated 2018-02-21. It names one FDA 510(k) clearance: K052549. Product: LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.. Reason: LeadCare II Test Kits controls out of range.

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Terminated: 2018-02-21
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 Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

Reason for recall

LeadCare II Test Kits controls out of range

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