Z-0902-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2015
- Initiation Date
- November 13, 2014
- Termination Date
- March 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 443 units
Product Description
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Reason for Recall
HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes
Distribution Pattern
Nationwide in US
Code Information
Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.