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.
Reported: April 11, 2018 Initiated: January 9, 2018 #Z-1295-2018
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.
Details
- Recalling Firm
- Magellan Diagnostics, Inc.
- Units Affected
- 6,143
- Distribution
- Worldwide Distribution
- Location
- North Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Magellan Diagnostics, Inc.. Units affected: 6,143.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 11, 2018. Severity: Moderate. Recall number: Z-1295-2018.
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