Recall Z-1296-2018— Magellan Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Magellan Diagnostics, Inc., initiated 2018-01-09, terminated 2020-12-11. It names one FDA 510(k) clearance: K142705. Product: LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.. Reason: 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..
- Recalling firm
- Magellan Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-09
- Terminated
- 2020-12-11
- Firm location
- North Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.