# FDA recall Z-2963-2020

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2020-08-11.

## Product

Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

## Reason for recall

An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin.  Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

## Distribution

US Nationwide distribution including in the states of WV, and Puerto Rico.

## Key facts

- **Recall number:** Z-2963-2020
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-11
- **Report date:** 2020-09-23
- **Termination date:** 2020-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2963-2020

## Citation

> AI Analytics. FDA recall Z-2963-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2963-2020. Source: US FDA. Licensed CC0.

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