Z-1295-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- January 9, 2018
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,143
Product Description
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 Pattern
Worldwide Distribution
Code Information
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.