Z-2962-2020Class II

Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 -

Name: Z-2962-2020 Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 -
Creator: Randox Laboratories Ltd.
Published: 2020-08-11
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-08-11 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate... on 2020-08-11. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2962-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-11
Posted: 2020-09-12
Terminated: 2020-10-15
Recalling firm: Randox Laboratories, Limited
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 RX daytona and RX imola.
Product code: CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 21
Distribution: US Nationwide distribution including in the states of WV, and Puerto Rico.
Product codes and lots: GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2962-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2962-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11
Z-2963-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code CFJ

K970684Class IILactate Dehydrogenase (Ld)Randox Laboratories, Ltd. / cleared 1997-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)