Ortho-Clinical Diagnostics: Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Agency Publication Date: January 14, 2015

Affected Products

Product: VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoas

Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Product: VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69830

Status: Resolved

Manufacturer: Ortho-Clinical Diagnostics

Manufactured In: United States

Units Affected: 3 products (658 total: USA - 144, Foreign - 514; 339 Total: USA - 102, Foreign - 237; 1830 Total: USA - 877, Foreign - 953)

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Sources: FDA iRES · Raw API Response

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Affected Products

Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)