Every recall we track for Randox Laboratories Ltd. — 77 in all — plus the complaints and injury reports the public filed about them.
Randox recalls all CYSC Cystatin C reagents for IVD use due to missing FDA 510(k) clearance. This affects lab tests requiring the reagent. No action needed as the product is not for consumer use.
Randox recalls Evidence MultiSTAT drug testing devices with software v3.7 due to potential light leaks affecting test results. Affected units may delay reporting results.
Randox recalls Clinical Chemistry Calibration Serum (Cal2351) due to potential inorganic phosphate bias on RX Series instruments. Affected lots may cause inaccurate test results. Contact Randox for details.
Randox recalls C3 and Haptoglobin liquid protein calibrators (IT2691) used with IgA/IgG/IgM assays due to realignment to ERM-DA470k/IFCC reference material. No immediate safety risk reported.
Randox recalls specific batches of Cystatin C Calibrator (CVS 2699) due to negative bias in lab testing. Affected units may give inaccurate results for cystatin C assays.
Randox recalls Microalbumin Calibrator Series (mALB CAL) for potential misclassification of patient results due to negative bias in calibration. Affected units may show up to +12% shift in quality control and patient sample recovery.
Randox recalls Microalbumin Calibrator Series (mAL:CAL) MA1567 and MA2426 due to potential misclassification of patient results. Users may see up to +12% shifts in quality control and sample recovery.
Randox recalls RX Series Copper (Cu) Assay Ref. CU2340 due to risk of falsely elevated copper results when run after total protein tests. Affected units have specific batch numbers.
Randox recalls Calibration Serum Level 3 CAL2351 (lot numbers 1214UE-1315UE) due to potential 13% shift in test accuracy on RX Series instruments. Affected users should contact Randox for guidance.
Randox recalls Calibration Serum Level 3 (CAL2351) due to misassigned Alkaline Phosphatase target causing inaccurate test results. Affected units may have errors in clinical chemistry assays.
Randox recalls Calibration Serum Level 3 (CAL 3) and Human Assayed Multi-Sera Level 2 (HN1530) due to transcription errors in instructions for bilirubin, triglycerides, and TBIC target values. Affected lots expire by November 2024 to May 2025.
Randox recalls Serology ToR: 2022 Positive Control kits due to reduced reactivity of HSV Type 1/2 lgM when tested on DiaSorin Liaison XL. Affected kits may give inaccurate results in lab tests for CMV, Rubella, Toxoplasma, and Herpes Simplex.
Randox recalls Total Bilirubin test kits due to reports of inaccurate results with plasma samples. Affected kits include specific catalog numbers and all batches. No remedy is listed in the recall notice.
Randox recalls RX Daytona Plus analyzers (RX4041 and RX4041R) due to potential incorrect re-run settings causing sample errors. Affected units have specific lot numbers. Contact Randox for details.
Randox recalls RX Daytona Plus analyzers (catalog RX4040) due to potential incorrect re-run settings causing inaccurate test results. Affected units have specific lot numbers.
Randox recalls RX4900 clinical chemistry analyzers with potential for incorrect sample re-runs due to parameter settings. Affected units may report inaccurate results if samples are outside assay ranges.
Randox recalls RX Monaco-IVD Clinical Chemistry Analyser (RX5000) due to potential incorrect sample rerun settings causing inaccurate test results. Affected units may need recalibration or software updates.
Randox recalls RX9000 clinical chemistry analyser due to potential incorrect re-run settings causing inaccurate test results. Affected units may need correction to prevent errors in lab testing.
Randox recalls Liquid Assayed Chemistry Control Premium Plus Level 3 (LAE4215) due to incorrect Caeruloplasmin values in instructions. Most labs use target values safely, but misreporting risks patient errors.
Randox recalls specific batches of liquid protein calibrators due to potential 10% higher ferritin results. Affected batches include 627222, 627224, 634886, and 634887. No action is required for users.
Randox recalls urine control kits with potential for incorrect hCG and cortisol results, causing delays in patient testing. Affected kits may have vial variations or transcription errors in instructions.
Randox recalls specific urea assay kits that may cause false low urea results if used immediately after LDL cholesterol tests, potentially delaying accurate patient results.
Randox recalls Immunoassay Premium Control Tri Level kits for potential delay in reporting test results due to quality control issues. Affected kits have specific batch numbers and expiration dates.
Randox recalls Immunoassay Premium Level 3 quality control kits for potential delays in test results due to high recovery values outside the acceptable range on Roche Cobas e801 analyzers.
Randox recalls specific batches of Liquid Assayed Specific Protein Control Level 3 for in vitro diagnostics. Low Rheumatoid Factor concentration may cause delays in test results. Affected batches have catalog numbers PS2684 and lot numbers 586LPC, 602LPC, 628LPC.
Randox recalls Specific Protein Control Levels 1-3 for potential delayed test results due to low concentration of Rheumatoid Factor. Affected units include specific lot numbers and dates.
Randox recalls specific protein control levels 2 for potential delayed test results due to reduced rheumatoid factor concentration. Affected units have catalog numbers PS2683 and GTIN 05055273204902.
Randox recalls IgA and IgM blood test kits (IA3832) due to potential inaccurate results if used immediately after specific fructosamine tests. All lots affected.
Randox recalls IgM Immunoturbidimetric Assay (Catalog IM3834) due to potential inaccurate test results from improper use with specific fructosamine tests.
Randox recalls Serology I Positive Control vials that may test negative for HBsAg, causing delays in patient results. Affected units contain specific lot numbers and expiration dates.
Randox recalls cholesterol test kits that may produce inaccurate results due to reduced linearity in calibration. Affected kits have specific catalog numbers and expiry dates. Consumers should contact Randox for guidance.
Randox recalls STFR CAL calibrators for Siemens Atellica CH analyzers due to atypical calibration curves causing non-numerical results. Affected lots may underestimate results by up to 30%.
Randox recalls STFR reagents for research use only due to calibration issues with Siemens Atellica analyzers causing non-numerical results in low concentration ranges. Affected lots reported.
Randox recalls CK MB Calibrator model CK2393 (lot 441:0CK) due to potential 6% calibration shift affecting test accuracy. Affected units may need recalibration or replacement.
Randox recalls cholesterol test system (REF CH200) due to calibration errors causing high results. Affected lots from June 2022 to July 2023. No remedy stated in official notice.
Randox recalls NEFA CAL IVD standard (FA115) due to incorrect calibration causing up to +8% false high results in patient tests. Affected batches expire Nov 2022.
Randox recalls RX Imola Analyser with ISE models RX4900/RX4900R due to software freezing during command processing, resulting in no test results. Affected units have specific serial numbers and catalog codes.
Randox recalls Calibration Serum Level 3 (CAL 3) with batch 1162UE due to potential positive bias in bilirubin tests. Affected users should check their batch numbers and contact Randox for guidance.
Randox recalls Mg test kits that may show inaccurate magnesium levels in serum/plasma due to reduced linearity. Affected kits have specific catalog and lot numbers.
Randox recalls Mg R1 kits for inaccurate magnesium testing in serum/plasma/urine due to linearity issues. Affected kits may give unreliable results.
Randox recalls LDH test devices (catalog LD3842) due to potential inaccurate patient results from reagent carryover. Affected units may cause delayed testing or false high readings. Contact Randox for details.
Randox recalls Lactate Dehydrogenase P-L (UV) device (LD381: LD3818) for possible test errors due to reagent carryover. Affected units may cause delayed patient results or false high readings. Contact Randox for details.
Randox recalls AM1054 ammonia reagents due to potential overestimation of ammonia levels in patient samples. Affected units may cause inaccurate test results.
Randox recalls AM1015 Ammonia reagents due to potential positive bias in patient samples. This may lead to inaccurate ammonia levels in blood tests. Affected units include specific lot numbers.
Randox recalls Pancreatic Amylase AY3855 batch 480483 due to failing to meet performance claims before its 2020 expiry date. Affected units may not function correctly in lab tests.
Randox recalls specific batches of Amylase Ethylidene Blocked-pNPG7 Reagent due to performance failures before expiry. Affected units may not function correctly as intended.
Randox recalls specific lipase reagent batches due to imprecision in patient sample testing. Affected products include LI3837, LI7979, LI8050, LI8361 with certain lot numbers. Users should stop using these reagents to prevent inaccurate test results.
Randox recalls specific Lipase Colorimetric R1 Buffer batches due to imprecision in patient sample testing. Affected units may cause inaccurate test results. Contact Randox for details.
Randox recalls specific Lipase Colorimetric R2 Substrate batches due to imprecision in patient sample testing. Affected units may yield inaccurate lipase test results.
Randox recalls Chemistry QC Premium Plus (LAL4213) due to incorrect sodium control target values for in vitro diagnostics. This may affect lab accuracy in diagnostic testing.
Randox recalls Liquid Clinical Chemistry Control (LAE4217) due to incorrect lipase value in specific lot. This may affect lab test accuracy. No action needed for most users.
Randox recalls specific batches of Rheumatoid Factor Standard (RF CAL) test kits due to calibration errors that could affect rheumatoid arthritis diagnosis accuracy. Affected kits may provide incorrect results if used without proper calibration.
Randox recalls liquid protein calibrators (SP CAL (LIQ)) due to inaccurate Rheumatoid Factor measurements. Affected units may cause incorrect test results for certain blood tests.
Randox recalls Urinalysis Control Level 2 (UC5034) due to incorrect leukocyte range for Siemens Multistix tests. This may cause inaccurate urine test results. Affected lots: 1020UC (exp. 28 May 2020).
Rando: Randox recalls calibration serum (lot 961UE+) with potential 10% AST and 9% ALT errors affecting clinical tests. No remedy stated in official notice.
Randox recalls G-6-PDH Deficient Control (PD2617) due to incorrect target values in specific lots. This may affect blood test accuracy. Affected lots include 687PD, 70: 700PD, 715PD.
Randox recalls G-6-PDH Normal Control kits with incorrect target values for glucose-6-phosphate dehydrogenase testing. Affected lots may cause inaccurate blood test results.
Randox recalls Liquid Cardiac Control models CQ5051-53 for possible NTproBNP measurement errors on Siemens Dimension EXL LOCI systems. Affected units may show lower results than expected.
Randox recalls BG5002 Blood Gas Control Level 2 due to pH range error in in-vitro diagnostics. This affects blood gas analysis quality control. No remedy specified in official notice.
Randox recalls Immunoassay Premium Plus Controls (model IA3109/IA3112) due to incorrect target value on value sheet for analyzers. This may affect diagnostic accuracy in lab testing.
