Ortho-Clinical Diagnostics: VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinic

Is my product affected?

VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Prod

• UPC 10758750002740
• UPC 10758750007110

Check against the official notice below — it lists the full affected range.

What happened

The VITROS 5600 Integrated System, Version 3.3.1 and below, has been recalled because a software anomaly may incorrectly extend the on-analyzer stability time for loaded VITROS Reagents. This issue affects 2,413 systems that were distributed nationwide in the United States. The affected devices include two product codes: 6802413 with two serial numbers, and 6802915 (refurbished units) with 53 listed serial numbers.

The affected consumer should consult the source document for specific remedial actions, as the recall record does not specify a remedy.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

Details from the source

Reason for recall: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Distribution: US Nationwide Distribution Quantity: 2413 Lot/code info: 1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing i2018-10-17
• Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any 2018-10-17
• Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any s2018-10-17
• Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any 2018-10-17
• Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in2018-10-17

All FDA (Device enforcement) recalls