The Recall Desk

FDA (Devices) recall action 86236

Randox Laboratories Ltd. recalled 2 products on 2020-09-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-09-23
Critical
0
Units
25

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-09-23

    Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance

    Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2020-09-23

    Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps

    Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.

    Product
    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - 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…
    Category
    Distribution
    3 states