Z-1296-2018 Class II Terminated
FDA device recall Z-1296-2018 was initiated by Magellan Diagnostics, Inc. on January 9, 2018 and is designated Class II. 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 rem… The recall status is terminated (terminated December 11, 2020). Affected quantity: 79.
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
- 79
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.
Distribution Pattern
Worldwide Distribution
Code Information
Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.