Z-0285-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- August 8, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,465 kits
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.
Distribution Pattern
Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
Code Information
Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09. Exp. Date:November 10, 2019