Recall Z-0840-2019— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2018-12-04, terminated 2020-06-18. It names one FDA 510(k) clearance: K182042. Product: Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368. Reason: 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-04
- Terminated
- 2020-06-18
- Firm location
- Crumlin (North), Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.