Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Recalls
Showing 21-30 of 30 recalls
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
An error in the assignment of the control range pH in Blood Gas Control
The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " 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 by email at technical.services@randox.com, or telephone +44 (0)28 9442 2413 or Email: vigilance@randox.com.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
On February 18, 2020, the firm notified customers of the action via emailed Urgent Medical Device Correction letters. Customers were informed of the incorrectly assigned control target and range value for Sodium using the ISE indirect method. The letter stated that the sections for Roche Cobas series and mean of all instruments has now been updated, and the updated value sheets were included with the email. The updated value sheets may also be found on www.randox.com. Customers were asked to take the following actions: - Review results generated with the affected batches in line with the clinical profile of the patient. -Discuss the contents of the notice with your Medical Director. -Complete and return the included response form within 5 working days. Distributors were asked to forward a copy of the notice to all affected customers. If you have questions or concerns, please contact Randox Technical Services: 866-4-RANDOX, or customersupportusa@randox.com
G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
The target values and ranges in these lots are incorrect.
Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. For questions contact Randox Technical Services.
Liquid Cardiac Control, CQ5051
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials. Customers were advised to take the following actions: - Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays. - Discuss the contents of this notice with your Medical Director. - Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays. - Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. - Contact your local Randox sales representative for alternative product details. You may contact the firm at technical.services@randox.com.
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to technical.services@randox..com within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Customer with questions may contact Randox Technical Services via e-mail technical.services@randox.com or by phone +44 (0) 28 9445 1070
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
The firm, Randox, notified the US distributor via email on 3 Dec 2018 with an "Urgent Medical Device Correction" letter dated 26 Nov 2018. The distributors and customers were instructed to remove the Value Sheet from existing stock and replace with the new Value Sheet and Important Notice. Customers were asked to take the following actions: " Please review all remaining stock and add the attached important notice to each kit. Replace the kit value sheet with the revised document provided. " Discuss the contents of this notice with your Medical Director. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services by email: maria.kelly@randox.com or +44 (0)28 9442 2413 or Tel: +1 304 728 2890 Toll Free 866 4 RANDOX or Email: Cheryl.O'Hagan@randox.com.
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. Customers were instructed to do the following: " 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. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to technical.services@randox.com within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagen
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
Randox Laboratories sent an Urgent Field Safety Notice dated June 6, 2017, sent to all global consignees on June 7, 2017, via e-mail. This includes the sole US consignee. Customers are advised to dispose of any existing stock and to contact technical support with respect to reimbursement for loss of material. The company will follow up every 2 weeks over a six week period with the consignees. For further questions, please call (304) 728-2890.
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides. A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.
Randex Laboratories sent an Urgent Field Safety Notice letter dated June 17, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the response section of this form technical.services@randox.com. For questions contact Randex Technical Service.
IgE Calibrator Series
According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
The firm plans on contacting each consignee about the recall.