FDA recall Z-1295-2018

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.

Reason for recall

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.

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-1295-2018