The Recall Desk
ModerateFDA (Devices)·Z-0967-2015·Announced 2015-01-21

Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly

Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software anomaly that may affect calibration identification without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System, Catalog Number 6802783. The recall affects 658 units distributed worldwide, including 144 units in the United States and 514 units in foreign countries. The affected units are identified by Software Version 3.1 and below and Serial Numbers J36000101 through J36000834.

The firm identified an anomaly in the software that may prevent the system from properly identifying an expired calibration. This issue could affect the accuracy of in vitro quantitative, semi-quantitative, and qualitative measurements of clinical analytes.

Healthcare facilities and laboratories should check their VITROS 3600 systems for the affected software versions and serial numbers. Users should contact Ortho-Clinical Diagnostics for instructions on how to resolve the software anomaly.

The recalled product

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
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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