Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2141-2014·Announced 2014-08-13

Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text does not report any hospitalizations or injuries. The hazard is a software anomaly affecting data integrity under specific conditions, which aligns with the criteria for a moderate severity score involving low-risk issues or voluntary precautionary measures without reported harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an anomaly identified in VITROS System Software Version 3.0 and below. The recall covers 838 domestic units and 949 foreign units distributed worldwide, including the United States, Puerto Rico, and various international markets.

Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. The VITROS 5600 Integrated System is used for the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest. The software issue affects the VITROS 3600, 4600, and 5600 Systems, which share the same software base.

The affected units have serial numbers ranging from J56000110 to J56001954. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the recall and software updates.

The recalled product

Product: VITROS 5600 Integrated System --- 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…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Equipment
Hazard: software-error
data-integrity

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 (2)

Serial Numbers J56000110 - J56001954 (J Numbers are analogous to Serial Numbers
for VITROS 5600 systems the J Numbers start with 5600XXXX)

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 →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · software error