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Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 -… recallZ-2963-2020 · Randox Laboratories Ltd. · initiated Aug 11, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Urgent Medical Device Correction notification letters dated 8/5/20 were issued to customers. Action to be taken: " Review your instrument testing order in line with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and enable additional pipette washes. " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0121) and ensure all operators are aware of the recommendations. " Discuss the contents of th is notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns, please contact Randox Technical Services.

Recall details

Recall number
Z-2963-2020
Status
Terminated
Initiated by the company
Aug 11, 2020
Recalling firm
Randox Laboratories Ltd.
Quantity
4
Product code
CFJ
FDA submissions
K970684
Distribution
US Nationwide distribution including in the states of WV, and Puerto Rico.

Product description

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.

Code information (models, lots, serial numbers)

GTIN: 05055273204117;  Lot Numbers: 511979

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K970684 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86236).

Sources and updates

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