The Recall Desk
HighFDA (Devices)·Z-1926-2017·Announced 2017-05-24

Magellan LeadCare Ultra Blood Lead Test Kits Recalled for Inaccurate Results

Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kits because they may generate falsely low lead concentrations when used with specific Becton Dickinson EDTA Vacutainer tubes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may produce inaccurate diagnostic results (falsely low lead levels), which poses a risk of harm by potentially delaying necessary treatment, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Magellan Diagnostics, Inc. is recalling LeadCare Ultra Blood Lead Test Kits, Part Number 80-0010. The recall involves 1,016 units distributed nationwide. The affected kit lots are 1309BU, 1310AU, 1312BU, 1404AU, and 1408BU.

The recall is due to a defect where the LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. This 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.

Healthcare providers and laboratories using these kits should stop using the affected lots and contact Magellan Diagnostics for instructions on how to proceed. Consumers should not use these kits for home testing if they have the affected lot numbers.

The recalled product

Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,016

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Kit lots: 1309BU
  • 1310AU
  • 1312BU
  • 1404AU
  • 1408BU

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Magellan Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Magellan Diagnostics, Inc.

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Same hazard · inaccurate diagnostic

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