PlainRecalls
FDA Devices Moderate Class II Terminated

LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

Reported: April 11, 2018 Initiated: January 9, 2018 #Z-1296-2018

Product Description

LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

Reason for Recall

The incorrect placement of AA batteries into certain LeadCare Plus 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.

Details

Units Affected
79
Distribution
Worldwide Distribution
Location
North Billerica, MA

Frequently Asked Questions

What product was recalled?
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.. Recalled by Magellan Diagnostics, Inc.. Units affected: 79.
Why was this product recalled?
The incorrect placement of AA batteries into certain LeadCare Plus 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1296-2018.