Z-0494-2018 Class II Terminated
FDA device recall Z-0494-2018 was initiated by Horiba Instruments, Inc dba Horiba Medical on November 21, 2017 and is designated Class II. Reason for recall: The ABX PENTRA Reagent Containers 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 inc… The recall status is terminated (terminated November 4, 2019). Affected quantity: 10 bags of 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- November 21, 2017
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 bags of 100 units
Product Description
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
Reason for Recall
The ABX PENTRA Reagent Containers 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.
Distribution Pattern
Nationwide
Code Information
DATE - MVT 25.08.2017