LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
This recall has been terminated (originally issued August 15, 2017).
- Company
- Magellan Diagnostics, Inc.
- Recall Initiated
- January 20, 2016
- Posted
- August 15, 2017
- Terminated
- February 21, 2018
- Recall Number
- Z-3035-2017
- Quantity
- 12,931 kits
- Firm Location
- North Billerica, MA
- Official Source
- View on FDA website ↗
Reason for Recall
LeadCare II Test Kits controls out of range
Distribution
Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
Lot / Code Info
Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17
Root Cause
Device Design
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..