The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1295-2018·Announced 2018-04-11

Magellan LeadCare II Blood Lead Analyzer Recalled for Battery Overheating Risk

Magellan Diagnostics is recalling LeadCare II Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 risk of burn injury from overheating batteries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Magellan Diagnostics, Inc. is recalling 6,143 units of the LeadCare II Blood Lead Analyzer. The affected units are identified by part numbers 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R, and include all LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O. These devices are intended for in vitro (external) use only and were distributed worldwide.

The recall is being issued because the incorrect placement of AA batteries into certain units may cause the batteries to overheat. This overheating creates a risk that a user could burn their fingers if the batteries are removed while hot.

Consumers should stop using the affected devices immediately. Users should check their device part numbers and battery board versions to determine if they are affected. For further instructions on how to resolve the issue, users should contact Magellan Diagnostics, Inc.

The recalled product

Product
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Manufacturer
Magellan Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
6,143

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 (3)

  • Part Numbers: 70-6760
  • 70-6529-R
  • 70-6760-P

Distribution

Distribution scope not specified by the agency.

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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