Every recall we track for Randox Laboratories, Limited — 12 in all — plus the complaints and injury reports the public filed about them.
Randox recalls Lipoprotein (a) assay for use on Roche Cobas c501 analyzers due to lack of 510(k) or PMA approval. Affected units have catalog number LP3403 and UDI-DI 05055273204421.
Randox recalls Lipoprotein (a) assay for Roche Cobas c501 analyzers due to missing 510(k) or PMA certification. Affected units have catalog number LP2757 and UDI-DI 05055273209198.
Randox recalls RX Daytona Plus analyzers with specific software versions due to sample display and color flagging issues in clinical labs. Affected models RX4040 and RX4041 require correction to prevent incorrect sample identification and IQC flagging.
Randox recalls Liquid Cardiac Controls CQ5052 due to reduced N-Terminal Pro-Brain Natriuretic Peptide recovery in recent batches. Affected units have specific batch numbers and expiration dates.
Randox recalls Liquid Cardiac Controls model CQ5051 due to decreased N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) recovery in recent batches. Affected units have specific batch numbers and expiration dates.
Randox recalls Liquid Cardiac Controls with catalogue number CQ5053 due to reduced N-TproBNP recovery in recent batches. Affected units may have inaccurate cardiac test results.
Randox recalls NEFA FA115 Lot 485343 due to not meeting performance claims. This batch should not be used in testing. Check your product details to confirm if affected.
Randox recalls RX Imola Model RX4900 due to sensor malfunction causing overheating and internal damage. Affected units have specific serial numbers.
Randox recalls RX Daytona models RX4040 and RX404: Risk of internal wire melting and scorch damage due to sensor malfunction. Affected units have specific serial numbers.
Randox recalls Human Assayed Multi-Sera Level 2 (HN1530) due to incorrect control values in specific lots. This may cause inaccurate diagnostic test results. Affected units include model HN1530 with serial numbers 1306UN, 1308UN, 1309UN.
Randox recalls Assayed Bovine Multi-Sera Level 1 Model AL1027 Lot 205SL due to potential bile acids measurement errors. Affected users should contact Randox for details.
Randox recalls Liquid Cardiac Control CQ5053 lot 4069CK due to shelf-life issues. The control may fall outside specified ranges, affecting accuracy.
