Z-3035-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2017
- Initiation Date
- January 20, 2016
- Termination Date
- February 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,931 kits
Product Description
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.
Reason for Recall
LeadCare II Test Kits controls out of range
Distribution Pattern
Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA
Code Information
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