RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom Recalls
Showing 1-3 of 3 recalls
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
The consumers were sent a letter via email dated July 10, 2020. This notice instructs customers to The distributors and customers will be instructed to: -Discontinue use of batches listed above immediately -Review your reagent inventory of these products and assess your laboratories needs for replacements. Proof of remaining kits will be required. -Discuss the contents of this notice with your Medical Director. -Complete and return the response form
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
The firm, Randox Laboratories Ltd., sent an "Urgent Medical Device Correction" letter dated 30th July 2020 to it customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: - Discontinue use of, quarantine and discard any stock of AM1015, batch 517541 and AM1054, batch 512103 immediately. - Review results generated with the affected batches in line with the clinical profile of the patient. - Discuss the contents of this notice with your Medical Director. -Review your reagent inventory of these products and assess your laboratory needs for reimbursement for discarded inventory. -Complete and return the response form 12187-QA to technical.services@randox.com within five working days. If you have any questions or concerns please contact Randox Technical Services. Local at Tel: +1 304 728 2890 Toll Free 866 4 RANDOX Email: customersupportusa@randox.com and PR at Tel: 1-787-701-7000 Email: Jose.Rosario@randox.com.
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.