Z-0839-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- December 4, 2018
- Termination Date
- June 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 225 kits
Product Description
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Reason for Recall
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
Distribution Pattern
WV, PR
Code Information
All lot codes