FDA recall Z-1296-2018

Product

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.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2018-01-09

Report date

2018-04-11

Termination date

2020-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2018