FDAClass IIApril 11, 2018

LeadCare II Blood Lead Analyzer recall

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.

Why was LeadCare II Blood Lead Analyzer recalled?

The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.

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.
Recalling firm
Magellan Diagnostics, Inc.
Quantity
6,143
Distribution
Worldwide Distribution
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls