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Terminated

Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

FDA Recall Z-0839-2019 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeCJY
Date Initiated2018-12-04
Date Terminated2020-06-18
Product Quantity225 kits

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.

Firm Action

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".

Root Cause

Device Design

Distribution Pattern

WV, PR

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974607RANDOX CALCIUMRandox Laboratories, Ltd. · 1998-02-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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