Z-0839-2019 Class II Terminated
FDA device recall Z-0839-2019 was initiated by Randox Laboratories Ltd. on Dec 4, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 18, 2020). Affected quantity: 225 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 4, 2018
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0839-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026