Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Hazard
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.
What You Should Do
Randox the US distributor contacted customers by email on 12/4/18 to advise of problem and provided an update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments.The instrument testing order should be reviewed in line with the updated technical bulletin. A revised letter issued 12 Feb 2019 to advise "reagent would be observed as inconsistencies in Quality control recovery which may lead to a delay in running patient samples or erroneous elevated / depressed test results".
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
- Brand
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- UPC
- All lot codes
Units Affected
225 kits