Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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: inaccurate-diagnostic
false-negative
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 →

Same manufacturer · Magellan Diagnostics, Inc.

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