Recall Z-0285-2019— Magellan Diagnostics, Inc.

Name: FDA recall Z-0285-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Terminated

Class II FDA medical device recall by Magellan Diagnostics, Inc., initiated 2018-08-08, terminated 2020-05-12. It names 2 FDA 510(k) clearances: K052549, K971640. Product: Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.. Reason: Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH..

Recalling firm: Magellan Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Terminated: 2020-05-12
Firm location: North Billerica, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEMEsa Biosciences, Inc.·cleared 2005-10-06
K971640 — LEADCARE BLOOD LEAD TESTING SYSTEMEsa, Inc.·cleared 1997-09-09

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 LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

Reason for recall

Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.

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