Agency classClass IOur severity:Severe FDA (Devices)·Z-2226-2017·Announced 2017-06-14

Magellan LeadCare Blood Test Kits Underestimate Lead Concentrations

Magellan Diagnostics is recalling LeadCare Ultra and Plus test kits because they may underestimate lead levels in venous blood samples.

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: "Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems"

Plain-English summary

Magellan Diagnostics, Inc. is recalling the LeadCare Ultra and LeadCare Plus test kits. These products are used for the quantitative measurement of lead in fresh whole blood for professional, in vitro diagnostic use only. The recall covers 6,018 kits distributed in the United States and internationally.

The recall is being issued because the test kits may underestimate the lead concentration of venous blood samples when analyzed with the LeadCare systems. This inaccuracy could lead to incorrect clinical assessments of a patient's lead exposure.

The affected products were distributed nationwide in the US and in numerous foreign countries, including Australia, Canada, China, and the United Kingdom. All lot codes are included in this recall. Healthcare professionals and laboratories using these kits should stop using them and contact the manufacturer for instructions on how to proceed.

The recalled product

Product: Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare 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.…
Manufacturer: Magellan Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-diagnosis
inaccurate-results

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 (1)

All lot codes

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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