Recall Z-2225-2017— Magellan Diagnostics, Inc.
Class I · Terminated
Class I FDA medical device recall by Magellan Diagnostics, Inc., initiated 2017-05-23, terminated 2021-07-08. It names one FDA 510(k) clearance: K971640. Product: Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.. Reason: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems.
- Recalling firm
- Magellan Diagnostics, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-05-23
- Terminated
- 2021-07-08
- 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
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Reason for recall
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Data sourced from openFDA. This site is unofficial and independent of the FDA.