The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2225-2017·Announced 2017-06-14

Magellan LeadCare Blood Lead Test Kits Recalled for Underestimating Results

Magellan Diagnostics is recalling LeadCare and LeadCare II test kits because they may underestimate lead concentrations 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 and LeadCare II Blood Lead Test Kits. These kits are used for the quantitative measurement of lead in fresh whole blood and are intended for professional use only.

The recall was initiated 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 diagnostic results.

A total of 171,979 kits are affected by this recall, with 153,447 units distributed in the United States and 18,532 units distributed outside the US. The affected products were distributed worldwide, including in numerous countries across North America, Europe, Asia, South America, and Africa. All lot codes are included in this recall.

The recalled product

Product
Magellan Diagnostics LeadCare and LeadCare II 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. Sensors…
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

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 →

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