Magellan Diagnostics LeadCare Ultra Blood Analyzer recall
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Why was Magellan Diagnostics LeadCare Ultra Blood Analyzer recalled?
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
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?
All serial numbers
- Product
- Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
- Recalling firm
- Magellan Diagnostics, Inc.
- Quantity
- 49 units
- Distribution
- Nationwide Distribution
- Recall date
- May 24, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)