LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of l
FDA device recall Z-3035-2017 · posted 2017-08-15 · Terminated
Recall details
- Recalling firm
- Magellan Diagnostics, Inc.
- Reason for recall
- LeadCare II Test Kits controls out of range
- Action taken
- Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DOF
- Quantity affected
- 12,931 kits
- Distribution
- Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
- Date initiated
- 2016-01-20
- Date posted
- 2017-08-15
- Date terminated
- 2018-02-21
- Location
- North Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |