Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro recall
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…
Why was Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Magellan Diagnostics, Inc.
- Quantity
- 1,465 kits
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.
- Recall date
- November 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)